MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 6 FR/7 FR

Catalog Number AI-06210-IK

Device Problem Failure to Capture (1081)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after initially positioning the probe in the ventricle, the catheter would not stimulate.Multiple repositioning maneuvers where attempted and the operator could not get any stimulation.The catheter was then discarded and a new one was used, and pacing was acquired immediately with the new catheter.There was no report of patient complications, serious injury or death.

Event Description

It was reported that after initially positioning the probe in the ventricle, the catheter would not stimulate.Multiple repositioning maneuvers where attempted and the operator could not get any stimulation.The catheter was then discarded and a new one was used, and pacing was acquired immediately with the new catheter.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of pacing catheter low/no signal is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all 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: PACING/PSI KIT: 6 FR/7 FR
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11365851
• MDR Text Key: 240370925
• Report Number: 3010532612-2021-00057
• 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: 02/03/2021

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-06210-IK
• Device Lot Number: 23F20F0034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1