MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 7 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number	IPN000074
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during cardio mems implant procedure, the catheter was inserted and was noted by the staff that the patient had a large right atrium (confirmed via x-ray).The large right atrium had the catheter prolapse on itself, which made it more difficult to advance the catheter.However, the catheter was able to be guided into the right atrium, right ventricle, and pulmonary artery.Eventually, the catheter was guided into the left branch of the pulmonary artery but couldn't advance as the catheter would not advance far enough down the selected vessel.Different approaches were made but were unsuccessful.The staff determined that perforation occurred somewhere on the right side of the heart.The implant was abandoned due to the complications.
Event or Problem Description
It was reported that during cardio mems implant procedure, the catheter was inserted and was noted by the staff that the patient had a large right atrium (confirmed via x-ray).The large right atrium had the catheter prolapse on itself, which made it more difficult to advance the catheter.However, the catheter was able to be guided into the right atrium, right ventricle, and pulmonary artery.Eventually, the catheter was guided into the left branch of the pulmonary artery but couldn't advance as the catheter would not advance far enough down the selected vessel.Different approaches were made but were unsuccessful.The staff determined that perforation occurred somewhere on the right side of the heart.The implant was abandoned due to the complications.
Additional Manufacturer Narrative
(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of catheter difficult to advance in patient is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: CATH PKGD: WEDGE 7 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11222847
• Report Number: 3010532612-2021-00012
• Device Sequence Number: 3846102
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN000074
• Device Catalogue Number: AI-07127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1