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

Model Number 150075

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Aortic Dissection (2491)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A 7f pulmonary artery wedge pressure catheter was used during a procedure.There was no damage on the catheter when it was removed.The balloon was inflated and the catheter was in good working condition.It is indicated that a dissection occurred in the distal left pulmonary artery, from the balloon on the catheter tip bobbing in and out of the pulmonary artery.This led to hemoptysis and intubation, and it was necessary to move the patient to another facility.The patient was stabilized, spent several days in a rehab facility and was discharged approx 8 days after the initial procedure.

Manufacturer Narrative

Cine image review: an image shows the complaint device in the pulmonary artery as reported by the account.The image is labelled with an a and a line that measures 7.3mm.It is possible that this measurement is for the reported dissection, though it is not possible to see the dissection in the image provided.A second contrast image was provided from a different orientation with labels a and b measuring 3.4mm and 7.4 mm respectively.It is possible that these measurements are for the dissection though it is not possible to see the dissection due to the labels.The guide wire and catheter are visible in the image.A third image was provided without contrast.The complaint device and guide wire are visible in the image and a label a corresponding to a measurement of 7.4mm.It is possible that this is the length of the dissection, though it is not possible to tell from the images provided.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: 7513557
• MDR Text Key: 108226426
• Report Number: 1220452-2018-00058
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20613994733652
• UDI-Public: 20613994733652
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: 150075
• Device Catalogue Number: 150075
• Device Lot Number: 0008939073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Date Device Manufactured: 01/03/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 93