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 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing records were reviewed and there were no nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications prior to shipment.The returned product evaluation confirmed the complaint received.The distal section of the pronto shaft was separated.The tip showed signs of damage but remained intact.It is possible when the pronto was removed from the body, it met resistance from the kinked guidewire and separated inside the body.The damage at the point of separation was consistent with forcefully pulling against resistance.

Event Description

The pronto lp broke off in the patient when trying to pull it back out of the patient.The site was trying to aspirate a large clot from the arm, but clot was too big, when pulling back out of the patient, the pronto detached away from the guidewire and stayed in the patient.They were able to snare out piece of the pronto that was left in the patient.The account stated there was a very large kink in the wire when they pulled it out, which may have contributed to this issue.The patient was sent to surgery to fix the axillary artery since they were unable to fix it in the cath lab.Additional information received 25mar2019 reported there was a kink in the wire, which might have caused resistance.

• 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: 8527869
• MDR Text Key: 142373270
• Report Number: 2134812-2019-00023
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083784
• 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: 03/19/2019

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 Expiration Date: 09/19/2020
• Device Model Number: 5010
• Device Lot Number: 634079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 87