MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L

Catalog Number AI-07155-IK

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).See mdr# 3010532612-2020-00378 ((b)(4)) as the report is related to the same patient.

Event Description

It was reported that when the temporary pacing catheter was in use, it was noted that the catheter's cath-gard shield perforated and blood crept back up through the introducer.As a result, the catheter was taken out of the patient without consequence and transferred to a different hospital.

Manufacturer Narrative

(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of cath-gard leak is not able to be confirmed.The root cause of the complaint is undetermined.The lot number reported was incorrect, therefore, a device history record (dhr) review was unable to be completed.The lot number history for this account was unable to be retrieved.If the lot number information is available at a later date, the complaint will be updated accordingly.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00378 ((b)(4)) as the report is related to the same patient.

Event Description

It was reported that when the temporary pacing catheter was in use, it was noted that the catheter's cath-gard shield perforated and blood crept back up through the introducer.As a result, the catheter was taken out of the patient without consequence and transferred to a different hospital.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10970560
• MDR Text Key: 220913281
• Report Number: 3010532612-2020-00386
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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 Catalogue Number: AI-07155-IK
• Device Lot Number: 23F20H0811
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1