MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER; CATHETER

Model Number	5567
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The trapliner device was returned for evaluation.Manufacturing records were reviewed and there were no nonconformances related to this lot.The trapliner was returned with a balloon catheter stuck at the distal tip of the trapliner with the balloon deflated.The shaft of the trapliner was severely damaged.The distal tip section was pulled back and the shaft collapsed on itself.Two holes were found along the trapliner shaft.The coil in the trapliner were broken and exposed through the shaft.The proximal half-pipe was peeled away from the hypotube but remained intact.Longitudinal scuff marks were present along the proximal shaft of the trapliner.This damage is consistent with concomitant device interaction and unintended user error.
Event or Problem Description
The case was a cto/isr in an rca, no tortuosity.When trying to remove a balloon, it became stuck in trapliner.Physician removed trapliner and noticed the trapliner had accordioned, and he also saw a hole.An orbital atherectomy device was used to fracture the stent while the trapliner was in and multiple balloons were passed through the trapliner.This event occurred at the end of the case, so they did some final balloon inflations to complete case.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8965130
• Report Number: 2134812-2019-00062
• Device Sequence Number: 2151370
• Product Code: DQY
• UDI-Device Identifier: 20841156102132
• UDI-Public: (01)20841156102132
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• 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): 08/06/2019

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: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 5567
• Device Lot Number: 652250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/05/2019
• 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: Required Intervention