MAUDE Adverse Event Report: MEDTRONIC, INC PWP CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 150075

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Three pulmonary wedge pressure catheter were attempted to be used during a procedure to treat a non tortuous, non calcified veinous system in the right hearth cath.There was no damage noted to the packaging of the devices.The devices were removed from packaging per ifu with no issues.The devices were inspected with no issues.It was reported that an attempt was made to float the pulmonary wedge pressure catheter with the balloon inflated through a previously implanted venous stent and the stent struts burst the balloon.The procedure was complete by passing another pulmonary wedge pressure catheter uninflated through the stent.It was reported that there was no issue with the catheters that had the ruptured balloons.The patient is alive with no injury.

Manufacturer Narrative

It was reported that the unknown brand venous stent looked ok after interaction with the pulmonary wedge pressure balloons.The usual medium, and volume of medium (mls) was used as with several other successful procedures.The physician assessed that the venous stent caused the ruptured balloons.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PWP CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9859268
• MDR Text Key: 184314604
• Report Number: 1220452-2020-00035
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00613994733658
• UDI-Public: 00613994733658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884065
• 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,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: 150075
• Device Catalogue Number: 150075
• Device Lot Number: 0009874487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Date Device Manufactured: 08/14/2019
• 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