MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TWINPASS V2; DUAL ACCESS CATHETER

Model Number	5200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: tip broke off at end of case when pulling it out of the hemostasis device.Additional information: the procedure was a pci.The catheter was prepped and flushed without any issue.The patient is reported as fine post the procedure.Additional information has been requested from the account.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.Unit was manufactured at tecate.A dhr review was completed for lot 73c2200433.No issues or nonconformances were noted.Case details were reviewed.Customer stated "tip broke off at end of case when pulling it out of the adapter valve, hemostasis device ".No unit was returned to vsi/teleflex for evaluation.It is unknown what damages have occurred on the shaft and how much of the tip was separated.Additional information was requested.A response was received.Twin pass was prepped without any issues.No pictures were shared on tip separation.The point of fracture is unknown.It is likely that the adapter valve hemostasis device was in a locked position when the catheter was pulled.This could lead to separation because of friction when operated against resistance.However, without a confirmation from the account, it is undeterminable.Per ifu states the following warning and precaution 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.Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported that: tip broke off at end of case when pulling it out of the hemostasis device.Additional information: the procedure was a pci.The catheter was prepped and flushed without any issue.The patient is reported as fine post the procedure.Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).One unit of twin pass (lot: 73c2200433) was returned.Blood particulates were noted on the unit.Approximately 1.5 cm of the distal tip was observed to be separated.The guidewire lumen was observed to be torn.As per additional information received, twin pass was prepped without any issues.No pictures were shared on tip separation.Damages noted on the tip and lumen indicate operation against resistance.It is likely that the tuohy was in a locked position when the catheter was pulled or caught within the tuohy system when retrieved.The tuohy unit was not returned.The ifu along with the product states: 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.Exercise care in handling of the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking.A manufacturing record review was completed, and no related non-conformances were found.Based on the information, the most likely r oot cause of the issue is operational context and or unintended use error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: tip broke off at end of case when pulling it out of the hemostasis device.Additional information: the procedure was a pci.The catheter was prepped and flushed without any issue.The patient is reported as fine post the procedure.Additional information has been requested from the account.

• Brand Name: TWINPASS V2
• Common Device Name: DUAL ACCESS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17698668
• Report Number: 2134812-2023-00045
• Device Sequence Number: 6719221
• Product Code: DQY
• UDI-Device Identifier: 10841156100353
• UDI-Public: 10841156100353
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/14/2024
• Device Model Number: 5200
• Device Catalogue Number: 5200
• Device Lot Number: 73C2200433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 08/11/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/06/2023; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Male