MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC TWIN-PASS .023; DUAL ACCESS CATHETER

Model Number	5230
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product evaluation confirmed a piece of the distal tip was separated and not returned with the device.Twin-pass.023 was returned to vsi for evaluation and about 1.5cm of the distal tip was separated from the catheter.The separated piece was not returned with the device, the tip looked to be stretched just proximal of the break.Biological contamination was present on the catheter.A manufacturing record review was completed and zero nonconformances were found.The damage found is consistent with pulling the catheter against resistance causing the separation.The most likely root cause is damage during use.
Event or Problem Description
Physician used twinpass in cto case, part of distal tip of twinpass broke off and stuck on wire.The twinpass tip broke as they were advancing it onto the wire, it never went into the patient.The piece of the tip got thrown away.The catheter was not torqued.

• Brand Name: TWIN-PASS .023
• Common Device Name: DUAL ACCESS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7068302
• Report Number: 2134812-2017-00101
• Device Sequence Number: 18848919
• Product Code: DQY
• UDI-Device Identifier: M20652300
• UDI-Public: M20652300
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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
• Operator of Device: Physician
• Device Expiration Date: 12/06/2018
• Device Model Number: 5230
• Device Lot Number: 601601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/29/2017
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 84