MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 6 FR 110 CM

Catalog Number AI-06210

Device Problem Failure to Capture (1081)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after the pacemaker electrode was inserted and connected to the pacemaker source, no signal is observed on the monitor.As a result, another device was used successfully.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4), the product was not returned for investigation.The reported complaint of pacing catheter low/no signal is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revised risk.This will be monitored for any developing trends.

Event Description

It was reported that after the pacemaker electrode was inserted and connected to the pacemaker source, no signal is observed on the monitor.As a result, another device was used successfully.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: PACING 6 FR 110 CM
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12169725
• MDR Text Key: 263459767
• Report Number: 3010532612-2021-00198
• 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: 06/15/2021

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
• Device Lot Number: 16F20F0045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1