MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC PRONTO .035; CATHETER

Model Number 5040

Device Problem Separation Problem (4043)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

One-unit model 5040 pronto 035 was returned to vsi for evaluation.The distal tip was separated from the catheter.There was damage to the catheter guidewire lumen just proximal to the separation point.The manufacturing record review shows no other non-conformance.Per the instruction for use pronto 035 is contraindicated for the removal of pulmonary embolism.

Event Description

It was reported that the physician was treating a pulmonary embolism with a 10f pronto and when he was in the left pulmonary artery, he retracted the guidewire to begin aspiration but the distal tip of the pronto catheter sheared off and floated into the right pulmonary artery where it was unable to be retrieved.The physician then used a catheter system to remove thrombus to complete the thrombectomy procedure.They tried to retrieve the broken tip of the pronto but were unable to reach it.It was noted that the patient was stable and is recovering nicely in the hospital however, the pronto tip was still inside the patient.No further complications were reported.

• Brand Name: PRONTO .035
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, mn ; 6564230
• MDR Report Key: 9695466
• MDR Text Key: 188826108
• Report Number: 2134812-2020-00014
• 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: 01/20/2020

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: 12/13/2021
• Device Model Number: 5040
• Device Lot Number: 664387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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: 80 YR
• Patient Weight: 118