MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC MINNIE SUPPORT CATHETER; PERCUNTANEOUS CATHETER

Model Number 5708

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no non-conformances related to this lot were identified; therefore, supporting the device met material, assembly and performance specifications prior to shipping.The returned product evaluation confirmed the issue reported.There was a kink and hole in the same location on the catheter shaft about 28cm from the distal tip.The distal and proximal id/od met the print requirements.Subassembly tubing exceeded the bend radius requirement; the catheter is conforming to the specifications.Operational context likely caused the catheter to kink, which deformed shaft material and allowed the guidewire to exit the catheter.

Event Description

The minnie catheter was delivered contralateral over the wire.The wire was removed, and another wire advanced through the minnie, when the wire got to the segment of catheter at the bend of iliac bifurcation, the wire went through the plastic of the minnie and extruded out of the catheter traversing the aorta.There were bilateral stents in the proximal bifurcation of the iliac and the circulating nurse described the minnie as being kinked before the wire was advanced through.The wire did not dissect or perforate the vessel.There was no patient injury reported.

• Brand Name: MINNIE SUPPORT CATHETER
• Type of Device: PERCUNTANEOUS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8379404
• MDR Text Key: 137451191
• Report Number: 2134812-2019-00012
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 5708
• Device Lot Number: 631910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 36