MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC PRONTO LP; CATHETER

Model Number 5010

Device Problem Separation Problem (4043)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing records were reviewed for both potential lot numbers that were reported (631471 and 640065).No issues or non-conformances were identified for either lot, therefore supporting that the device met material, assembly and performance specifications prior to shipment.The pronto lp was returned for evaluation, and the unit was severely damaged.The complaint was confirmed as the tip of the pronto lp was missing from the catheter, exposing the polyimide tubing.The over the wire lumen was split from the proximal port to the distal tip separation.This damage is consistent with a guidewire tearing through the polyimide tubing upon removal from the body.The tip damage and separation is most likely associated to the operational context as interaction with plaque in the patient's vessel may have damaged the pronto lp tip to the point of separation.

Event Description

Using a radial access, the guidewire was used to successfully cross the lesion with no complications and was removed with no complications.However, vessel appeared to be occluded with both plaque and clot.It is reported that the tip of pronto lp broke off in the occluded vessel.Patient tolerated procedure well and recovered with no apparent harm done.Patient was successfully intervened later.The tip of catheter was found to have drifted further distal than original location, and the decision was made to leave the tip in place.

• Brand Name: PRONTO LP
• Type of Device: 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: 8478966
• MDR Text Key: 140804934
• Report Number: 2134812-2019-00018
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5010
• Device Lot Number: TWO DIFFERENT LOT #'S REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 106