MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC PIGGYBACK WIRE CONVERTER; PERCUTANEOUS CATHETER

Model Number	8802
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed and no related nonconformances were found, therefore supporting the device met material, assembly and performance specifications.Multiple attempts were made to gather more information regarding the event but were unsuccessful.The root cause is undeterminable.
Event or Problem Description
Reported as marker band came off the piggyback.Medwatch uf/importer# (b)(4) was received 15may2020.The description from the medwatch states: radiopaque marker broke off catheter while inside patient.Device failed (e.G., broke couldn't get it to work or stopped working.Multiple attempts were made to obtain the device for investigation and further information for this complaint.No response was received.

• Brand Name: PIGGYBACK WIRE CONVERTER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10139542
• Report Number: 2134812-2020-00035
• Device Sequence Number: 11671582
• Product Code: DQY
• UDI-Device Identifier: 10841156101657
• UDI-Public: (01)10841156101657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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: 10/16/2021
• Device Model Number: 8802
• Device Catalogue Number: 8802
• Device Lot Number: 660235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR