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

Model Number	150075
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9859268
• Report Number: 1220452-2020-00035
• Device Sequence Number: 14106248
• Product Code: DQO
• UDI-Device Identifier: 00613994733658
• UDI-Public: 00613994733658
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K884065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 08/13/2021
• Device Model Number: 150075
• Device Catalogue Number: 150075
• Device Lot Number: 0009874487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1