MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07124
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "during the right heart catheterization portion of the cardio mems implant procedure, prior to any cardiomems equipment being opened or used, the patient had a bradycardiac arrest.This happened when the physician attempted to advance the arrow balloon wedge pressure catheter from the right atrium to the right ventricle.Cardiomems implantation was aborted.The patient received atropine and compressions, and was externally paced following the event.It was noted the patient has a baseline right bundle branch block.Patient is stable and discharged".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the reported complaint of catheter difficult to advance in patient was not able to be confirmed as the product was not returned for investigation.A device history record (dhr) review was unable to be completed as no lot number was reported.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "during the right heart catheterization portion of the cardio mems implant procedure, prior to any cardiomems equipment being opened or used, the patient had a bradycardiac arrest.This happened when the physician attempted to advance the arrow balloon wedge pressure catheter from the right atrium to the right ventricle.Cardiomems implantation was aborted.The patient received atropine and compressions, and was externally paced following the event.It was noted the patient has a baseline right bundle branch block.Patient is stable and discharged".

• Brand Name: CATH PKGD: WEDGE 5 FR 110CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18427026
• Report Number: 3010532612-2024-00007
• Device Sequence Number: 12695431
• Product Code: DYG
• UDI-Device Identifier: 00801902002853
• UDI-Public: 00801902002853
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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 Catalogue Number: AI-07124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown