MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PACING/PSI KIT: 5 FR/6 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number AI-07155-IK

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

The report states "white adapter that connects introducer to catheter contamination shield snapped / broke during use allowing [reflux] of blood into shield/sleeve and required removal of the pacer wire and new insertion".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The reported complaint of "white adapter that connects introducer to catheter contamination shield snapped / broke" was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.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

The report states "white adapter that connects introducer to catheter contamination shield snapped / broke during use allowing [reflux] of blood into shield/sleeve and required removal of the pacer wire and new insertion".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 18257138
• MDR Text Key: 329613664
• Report Number: 3010532612-2023-00684
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: AI-07155-IK
• Device Lot Number: 13F22F0453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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