MAUDE Adverse Event Report: CORDIS CORPORATION CATH ST 5F SIM 2 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532502

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot: 18128889 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f sidewinder simmons ii (sim2) super torque diagnostic catheter was attempted to be adjusted when it got up to the brachiocephalic artery and catheter was not responding.The right common femoral artery (rcfa) was looked at and saw the catheter was kinked.It was attempted to unkink the catheter by twisting a little bit but it was noticed the catheter then broke off.The proximal portion of the sim2 super torque catheter was retrieved and removed.Then, the piece that had broken off was removed by vascular surgery with an unknown snare endovascularly.There was not reported patient injury nor was there permanent damage.The access site was rcfa and the proximal rcfa had tortuosity, 360 degree loop and had no stenosis nor calcification.This was a diagnostic case where the lesions were the right common carotid artery and brachiocephalic artery.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The product was prepped according to the ifu.No other damages were noted prior to inserting the product the product into the patient.There was no resistance met while advancing the device nor while advancing the device over the unknown guidewire.The device was not used for a chronic total occlusion (total occlusion >3 months).Excessive torqueing was not required.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 5f sidewinder simmons ii (sim2) super torque diagnostic catheter was attempted to be adjusted when it got up to the brachiocephalic artery and catheter was not responding.The right common femoral artery (rcfa) was looked at and saw the catheter was kinked.It was attempted to unkink the catheter by twisting a little bit, but it was noticed the catheter then broke off.The proximal portion of the sim2 super torque catheter was retrieved and removed.Then, the piece that had broken off was removed by vascular surgery with an unknown snare endovascularly.There was not reported patient injury nor was there permanent damage.The access site was rcfa and the proximal rcfa had tortuosity, 360-degree loop and had no stenosis nor calcification.This was a diagnostic case where the lesions were the right common carotid artery and brachiocephalic artery.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The product was prepped according to the ifu.No other damages were noted prior to inserting the product the product into the patient.There was no resistance met while advancing the device nor while advancing the device over the unknown guidewire.The device was not used for a chronic total occlusion (total occlusion >3 months).Excessive torquing was not required.The device was returned for analysis.A non-sterile unit of product ¿cath st 5f sim 2 100cm¿ was received coiled inside of a clear plastic bag, along with an unknown wire and unpacked for evaluation.The unit is separated at two pieces, and both segments were returned.The separation is located at 26 cm from the proximal end.The unit is kinked at approximately 52 cm from the distal tip.Per dimensional analysis.Measurements were taken at one cm from both separated edges and were found within specification.Sem analysis showed that the separated area of the body/shaft presented evidence of elongations on the plastic material and plastic deformation and diameter reduction on the metallic material (braidwire).The characteristics found on the materials of the unit are commonly associated with separations caused by material tensile overload.No other anomalies were observed during the sem analysis.The phr review for lot 18128889 was reviewed and no issues were noted that could be related to the reported complaint.The reported ¿catheter (body/shaft) kinked/bent - in-patient¿ and ¿brite tip/distal tip ¿ catheters ~ separated - in-patient¿ was confirmed.The unit was returned separated at two piece and a kink was observed on the body/shaft.While the exact cause for the events could not be conclusively determined there are patient and anatomical factors such as tortuosity and a 360-degree loop of the access vessel, along with procedural factors such as excessive torquing to navigate the vasculature from the common femoral artery to the brachiocephalic artery that may have contributed to the reported event.Catheter separation failures are commonly associated with elongations caused by material tensile overload.Therefore, it is assumed that the catheter was induced to a tensile force that exceeded its material yield strength prior to the separation.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿manipulation of the catheter under excessive friction due to interaction with other devices or while navigating the vasculature, can lead to stretching or elongation of the catheter.Based on the information available, the device analysis and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: CATH ST 5F SIM 2 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16218988
• MDR Text Key: 307883618
• Report Number: 9616099-2023-06230
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032011655
• UDI-Public: (01)10705032011655(17)250830(10)1812888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532502
• Device Catalogue Number: 532502
• Device Lot Number: 18128889
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDEWIRE; UNKNOWN SNARE