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

Catalog Number AI-07124

Device Problem Difficult to Insert (1316)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 11/16/2023

Event Type  Injury  

Event 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".

Manufacturer Narrative

(b)(4).

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 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
• Type of Device: 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
• MDR Text Key: 331860719
• Report Number: 3010532612-2024-00007
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002853
• UDI-Public: 00801902002853
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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