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

Catalog Number AI-06210

Device Problem Failure to Capture (1081)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was in need of electrical support with a transvenous pacemaker, change was made from introducer number 7.5 fr and external electrode 6 fr, due to its difficult advance capture, it is evident that this dysfunction in the distal end of the negative pole.As a result, the electrode was changed by connecting the patient to the defibrillator to place it in transcutaneous pacemaker mode while removing the dysfunctional transvenous electrode and advancing a new one through the same introducer.Possible failure in the connection of the distal end of the negative pole.The shift doctor performed a test peeling of the cable at the most proximal point and achieved reading but, this connection was unstable, so the device is changed.There was no patient death or serious injury reported.Patient current outcome reported as fine.

Event Description

It was reported that the patient was in need of electrical support with a transvenous pacemaker, change was made from introducer number 7.5 fr and external electrode 6 fr, due to its difficult advance capture, it is evident that this dysfunction in the distal end of the negative pole.As a result, the electrode was changed by connecting the patient to the defibrillator to place it in transcutaneous pacemaker mode while removing the dysfunctional transvenous electrode and advancing a new one through the same introducer.Possible failure in the connection of the distal end of the negative pole.The shift doctor performed a test peeling of the cable at the most proximal point and achieved reading but, this connection was unstable, so the device is changed.There was no patient death or serious injury reported.Patient current outcome reported as fine.

Manufacturer Narrative

(b)(4).The reported complaint of pacing catheter low/no signal is not confirmed.During functional testing, both the distal and proximal electrodes met product specifications.Although, the root cause of the complaint is undetermined the returned device passed functional test specifications.No further action required at this time.

• Brand Name: CATH PKGD: PACING 6 FR 110 CM
• Type of Device: TEMPORARY CARDIAC PACING BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8079227
• MDR Text Key: 127883505
• Report Number: 3010532612-2018-00344
• 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: 10/25/2018

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: 02/28/2023
• Device Catalogue Number: AI-06210
• Device Lot Number: 16F18C0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR