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

Model Number	5707
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One-unit model of a minnie v2 catheter was returned for evaluation.Blood particulates were found on the catheter.The catheter was decontaminated.During flushing, solution trickled outside the proximal end catheter confirming leakage.The leak was noted at 5.5 cm from the hub.No other damage was noted on the catheter.Investigation is still in progress.The cause of the issue is currently undeterminable.A follow-up report will be issued after investigation is complete.
Event or Problem Description
As reported: customer states during case they noticed the hub of the catheter to be cracked and thus blood trickling out of catheter.Additional information received 30jul2020: patient did not suffer any adverse effect.When physician noticed air bubbles, they exchanged catheter for a new one and proceeded as normal.There was no indication or concern of an embolus.
Additional Manufacturer Narrative
One unit of minnie v2 was returned to vs for evaluation.Blood particulates were found on the catheter.During flushing, the solution leaked out of the proximal end of the catheter, confirming that the catheter leaks.The leak was noted at 5.5 cm from the proximal end of the hub, just distal of the hub.A kink on the shaft was noted just distal to the distal end of the hub.The outer trilayer lumen at the location of the kink was cut down and the inner lumen was exposed.It was noted that the inner lumen was crimped and twisted severely.No other damage was noted on the catheter.Based on product evaluation, the catheter was over torqued.Per ifu, it states the following precaution" exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage, bending or kinking".Based on the information and returned product evaluation, the most likely root cause of the issue is operational context.

• Brand Name: MINNIE SUPPORT CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10437265
• Report Number: 2134812-2020-00047
• Device Sequence Number: 2743949
• Product Code: DQY
• UDI-Device Identifier: 30841156100807
• UDI-Public: (01)30841156100807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 07/02/2021
• Device Model Number: 5707
• Device Lot Number: 652929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 59