MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM LARGE BORE 71 CATHETER; CATHETER, ASPIRATION CATHETER

Model Number IC71132UG

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by a healthcare provider, during a thrombectomy case of a posterior stroke, a 132cm large bore 71 catheter (ic71132ug, lot unknown) was stretched and there were difficulties removing the device from the v1 v2 segment of the vertebral artery.There was no surgery delay due to the event.The procedure was completed successfully with another catheter.There was no patient injury reported.No fragments were generated.No additional intervention was required to remove the catheter from the patient.No excessive force was used at any time with the device.Adequate flush was maintained through the devices.

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: as reported by a healthcare provider, during a thrombectomy case of a posterior stroke, a 132cm large bore 71 catheter (ic71132ug, 3041152) was stretched and there were difficulties removing the device from the v1 v2 segment of the vertebral artery.There was no surgery delay due to the event.The procedure was completed successfully with another catheter.There was no patient injury reported.No fragments were generated.No additional intervention was required to remove the catheter from the patient.No excessive force was used at any time with the device.Adequate flush was maintained through the devices.One non-sterile 132cm large bore 71 catheter was received inside of a pouch.The received device was visually inspected and it was found with dry blood residues on it, a kinked condition was observed near to the hub and at 90 cm from proximal, also a slightly stretch condition was observed on the tip of the device.A manufacturing record evaluation was performed for the finished device 3041152 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿catheter (body/shaft) - unraveled/stretched¿ was confirmed, during the analysis, the catheter was found with a kinked and stretch condition, the stretch condition is related to the customer's complaint difficult to remove from the v1 v2 segment of the vertebral artery.The kinked and stretch conditions noted on the device is apparently related to the handling of the device at the procedure time, however, this cannot conclusively determine.The complaint reported by the customer ¿catheter (body/shaft) - withdrawal difficulty-from vessel¿ could not be duplicated because the complaint reported by the customer it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab.However, based on the event description and the findings during the analysis, the customer¿s complaint was confirmed.The stretch condition is a result of the withdrawal difficulty at the procedure time and an excessive force applied to the device at the removal time.The reddish material noted on the device is a physical phenomenon and it can be the normal result of the procedure.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the manufacturing process.Withdrawal difficulty is a known procedural occurrence.The instructions for use (ifu) warn the user to not advance or withdraw the intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.The movement of the device against resistance may cause vessel injury or damage to the device.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.As part of the 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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: 132CM LARGE BORE 71 CATHETER
• Type of Device: CATHETER, ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11019066
• MDR Text Key: 228512647
• Report Number: 3008114965-2020-00591
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082378
• UDI-Public: 10886704082378
• Combination Product (y/n): N
• PMA/PMN Number: K191237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: IC71132UG
• Device Catalogue Number: IC71132UG
• Device Lot Number: 3041152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1