MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TWIN-PASS; DUEL ACCESS CATHETER

Model Number	5200
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One unit of twin pass was returned to vsi/teleflex for investigation.A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.It was confirmed the tip of the catheter was sheared off.A small cut and minor bends were noted on the shaft of the catheter.The shaft material at the separation point was stretched signifying the catheter was pulled against some resistance.Per ifu: " never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in catheter damage or vessel injury".The account was asked for additional information on the procedure details, however, no response has been received.Based on the information and product evaluation, the most likely cause of the issue is operational context and/or unintended use error.
Event or Problem Description
As reported: twin-pass tip broke off in patient.Multiple attempts have been made to obtain additional information; however, no additional information has been received.

• Brand Name: TWIN-PASS
• Common Device Name: DUEL ACCESS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10401200
• Report Number: 2134812-2020-00046
• Device Sequence Number: 19581185
• Product Code: DQY
• UDI-Device Identifier: 10841156100353
• UDI-Public: (01)10841156100353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 5200
• Device Catalogue Number: 5200
• Device Lot Number: 668575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other