MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREBASE DA GUIDE SHEATH, 90CM; CATHETER, PERCUTANEOUS

Model Number GS9090SD

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Vasoconstriction (2126)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report from the field indicated that during a neurovascular procedure, the physician was accessing patient via transradial approach with cerebase da guide sheath 90cm (gs9090sd/30388356) and noted resistance in the brachial artery as he was advancing the sheath.The physician stopped advancing cerebase da at that point to determine next steps, which is when the decision was made to remove the cerebase da guide sheath.Upon trying to remove with various techniques, it was determined that the sheath was wedged or stuck and would not back out under normal guidance and/or force.The decision was then made to call vascular surgery to have it removed.The procedure was delayed as a result of the event, and fragments were generated.There were no known patient complications.The device is available for evaluation.No further information was provided at the time of complaint initiation.Additional information received on 24-jun-2020 indicated that the patient was a young female.The case was not a hemorrhagic case; the exact nature of the case is unknown, and physician is unwilling to discuss further.The physician performed radial access using ultrasound guidance but did not take a measurement of the radial artery (his routine standard of care).He had no difficulty tracking the device until he was in the area of the distal third of the brachial artery which he felt was after 20 to 30 cm of advancement.At this point he felt some resistance, which he believed to be standard, and continued to advance the catheter.On continued advancement, however, he encountered rapidly escalating resistance at which point he discontinued any further forward motion.His assumption was underlying vasospasm, which he has experienced with other large distal access catheters.He performed his standard of care for vasospasm including intra-arterial (ia) verapamil, ia nitroglycerin, and additional conscious sedation.The physician reattempted removal using significant force at which point the catheter tore and fragmented at the radial access site with the distal 20 to 30 cm of the catheter remaining within the patient¿s vessel.The patient was thereupon taken to the operating room (or) by vascular surgery for unknown corrective action.The physician stated that he is familiar with radial access and has done cases using a variety of access catheters.He has experienced vasospasm with the use of other distal access catheters but has never encountered a situation where the vasospasm could not be adequately treated.This was his first cerebase da case.The fragment external to the patient at the time of the initial procedure was retained by the physician and will be returned for evaluation.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this report: g4, g7, h2, h6, and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The photos provided by the customer were evaluated by the r&d team and they determined that the damages are located on the vistamind shaft, no transitions sections are involved.Also, they mentioned that is necessary to takes lots of force to break the polymer.They will need to see product to determine if any manufacturing issues.Photo analysis by product analysis lab (pal): based on the photos provided, it was observed that the distal tip of the devices has a damage condition with a braided wire exposed, also it can be observed some dry blood residues on the hub of the device.No other damages or anomalies were observed during the photo analysis.Mre review: a manufacturing record evaluation was performed for the finished device 30388356 number, and no non-conformance was found during the review.The complaint reported by the costumer ¿catheter (body/shaft) - tracking difficulty¿ could not be evaluated based on the information provided by the photos.The complaint reported by the costumer ¿catheter (body/shaft) - withdrawal difficulty-from vessel¿ could not be evaluated based on the information provided by the photos.The complaint reported by the costumer ¿catheter (body/shaft) - separated-in patient¿ was confirmed, during the photo analysis it can be observed exposed braided wire, this condition suggesting that one part of the device was separated from the rest of the device.Customer complaint was confirmed however, the device has not been returned for analysis therefore, it is not possible to determine the root cause of the failure.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a neurovascular procedure, the physician was accessing patient via transradial approach with cerebase da guide sheath 90cm (gs9090sd/30388356) and noted resistance in the brachial artery as he was advancing the sheath.The physician stopped advancing cerebase da at that point to determine next steps, which is when the decision was made to remove the cerebase da guide sheath.Upon trying to remove with various techniques, it was determined that the sheath was wedged or stuck and would not back out under normal guidance and/or force.The decision was then made to call vascular surgery to have it removed.The procedure was delayed as a result of the event, and fragments were generated.There were no known patient complications.The device is available for evaluation.No further information was provided at the time of complaint initiation.Additional information received on 24-jun-2020 indicated that the patient was a young female.The case was not a hemorrhagic case; the exact nature of the case is unknown, and physician is unwilling to discuss further.The physician performed radial access using ultrasound guidance but did not take a measurement of the radial artery (his routine standard of care).He had no difficulty tracking the device until he was in the area of the distal third of the brachial artery which he felt was after 20 to 30 cm of advancement.At this point he felt some resistance, which he believed to be standard, and continued to advance the catheter.On continued advancement, however, he encountered rapidly escalating resistance at which point he discontinued any further forward motion.His assumption was underlying vasospasm, which he has experienced with other large distal access catheters.He performed his standard of care for vasospasm including intra-arterial (ia) verapamil, ia nitroglycerin, and additional conscious sedation.The physician reattempted removal using significant force at which point the catheter tore and fragmented at the radial access site with the distal 20 to 30 cm of the catheter remaining within the patient¿s vessel.The patient was thereupon taken to the operating room (or) by vascular surgery for unknown corrective action.The physician stated that he is familiar with radial access and has done cases using a variety of access catheters.He has experienced vasospasm with the use of other distal access catheters but has never encountered a situation where the vasospasm could not be adequately treated.This was his first cerebase da case.The fragment external to the patient at the time of the initial procedure was retained by the physician and will be returned for evaluation.No further information was provided.Additional information received on 25-jun-2020 indicated that the da catheter was torn into two pieces as described by the physician.The proximal portion was removed and estimated distal 20-30 cm remained in the patient.The current status of the patient is unknown as the physician would not discuss.The physician stated that he used greater than normal force when trying to remove the device.There was an adequate flush maintained through the devices.No further information could be obtained.The photos provided by the customer were evaluated by the r&d team and it was determined that the damages are located on the vistamind shaft, no transitions sections are involved.It was also noted that it is necessary to take lots of force to break the polymer.Based on the analysis by the product analysis lab (pal) of the photos received, it was observed that the distal tip of the device has a damage condition with a braided wire exposed, also it can be observed some dry blood residues on the hub of the device.No other damages or anomalies were observed during the photo analysis.A manufacturing record evaluation was performed for the finished device 30388356 number, and no non-conformance was found during the review.The unit was received from c.G.Laboratories, inc.After decontamination.The proximal shaft (hub, id band and a section of vestamid) of the catheter was returned up to the suspected separation location, but the distal portion of the catheter was not returned.The returned portion of the unit in question was analyzed by the r&d team to determine the cause of the catheter separation during removal.After analysis of the unit, the r&d team concluded that the catheter became separated due to extreme tensile force being applied to the catheter¿s shaft.The failure resembles the failure observed on the shaft of cerebase da units during tensile testing.At the separation location, the polymer is necked down.This necking is like that seen on a unit that failed under tensile force.There is a slight angle on the broken polymer of the complaint unit, suggesting that a slight torqueing load accompanied the tensile force prior to failure.The braid did not fail (separate) as a result of tensile force.Given the manicured edges of the braid, it appears to have been cut with scissors, or some other sharp object.Once the polymer separated, the braid was stretched, extended, and became delaminated from the polymer.The failure reported by the costumer ¿catheter (body/shaft) tracking difficulty" was confirmed, due the conditions in which the device was found, these conditions may have been a result of the difficulty experienced by the user.The failure reported by the costumer ¿catheter (body/shaft) withdrawal difficulty-from vessel" was confirmed, due the conditions in which the device was found, these conditions may have been a result of the difficulty experienced by the user.The failure reported by the costumer ¿catheter (body/shaft) separated-in patient" was confirmed since the device was found separated in two pieces.Based on the investigation, it was concluded that the catheter became separated due to extreme tensile force being applied to the catheters shaft.The failure resembles the failure observed on the shaft of cerebase da units during tensile testing.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.Difficulty tracking a catheter through the vasculature is a known procedural occurrence.The consequences of tracking difficulty occurring during clinical use of the device are usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient anatomy, operator technique, and appropriate device selection.Withdrawal difficulty is also a known procedural occurrence.The cerebase instructions for use (ifu) states that an appropriately sized cerebase da guide sheath should be selected based on the patient anatomy and length.The ifu also warns the user to not advance or withdraw the intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance may cause vessel injury or damage to the device.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.This is a well-known extensively documented complication that can occur with any invasive procedure during which devices are introduced into vessels.With the information provided, it is not possible to determine the root cause of the event; however, vessel size/characteristics, device selection, and operator technique, are potential contributing factors.Post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: CEREBASE DA GUIDE SHEATH, 90CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10264523
• MDR Text Key: 205760949
• Report Number: 3008114965-2020-00278
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704082293
• UDI-Public: 10886704082293
• Combination Product (y/n): N
• PMA/PMN Number: K192805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: GS9090SD
• Device Catalogue Number: GS9090SD
• Device Lot Number: 30388356
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention