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

Catalog Number 150075

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis summary: the balloon was received soiled in media and dried blood.The balloon is severely torn.Proximal and distal seals remained intact.The inflation hole was filled with dried media and blood.No other damage noted to the inflation or flushing legs.The syringe is functional and without defect.Functional testing could not be performed due to the condition or damage to the returned device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was intended to use a pwp balloon catheter to measure valve gradients.No damage was noted to the packaging.The device was removed from packaging per ifu, inspected and prepped per ifu all with no issues noted.It is reported that the balloon would not inflate prior to use.The provided syringe was being used.The syringe is connected directly to the inflation leg.It was replaced with another pwp that worked successfully.Analysis of the returned device showed that the device was soiled with media and blood and had a severe rupture.It was then confirmed by the account that the device had been attempted to be used in the patient.During attempted inflation the balloon burst in vivo.The device was then removed from the patient and the procedure successfully completed using another pwp catheter.No injury reported.

• 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: 7968615
• MDR Text Key: 123800695
• Report Number: 1220452-2018-00121
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• 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