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

Model Number	150075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Aortic Dissection (2491)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7513557
• Report Number: 1220452-2018-00058
• Device Sequence Number: 13744279
• Product Code: DQO
• UDI-Device Identifier: 20613994733652
• UDI-Public: 20613994733652
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 93