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 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in the icu the staff could not obtain a capture with the temporary pacer wire.Multiple attempts were made at troubleshooting including pacer wire repositioning, review of settings, and obtaining a second external pacemaker with a new battery were tried, with no change.As a result, the decision was made to replace the wire with a new one.Immediately capture was obtained.Capture was then attempted with the original external pacemaker and was successful.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of pacing catheter low/no signal is confirmed.Upon function testing, continuity was present while the distal and the proximal electrodes were cross connected.This is consistent with a cross-connection between the electrodes, which caused the complaint.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.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.

Event Description

It was reported that in the icu the staff could not obtain a capture with the temporary pacer wire.Multiple attempts were made at troubleshooting including pacer wire repositioning, review of settings, and obtaining a second external pacemaker with a new battery were tried, with no change.As a result, the decision was made to replace the wire with a new one.Immediately capture was obtained.Capture was then attempted with the original external pacemaker and was successful.There was no report of patient complications, serious injury or death.

• Brand Name: PACING/PSI KIT: 6 FR/7 FR
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11273253
• MDR Text Key: 231139052
• Report Number: 3010532612-2021-00020
• 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: 01/18/2021

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 Expiration Date: 04/30/2022
• Device Catalogue Number: AI-06210-IK
• Device Lot Number: 23F17L0510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1