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 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "a second-degree atrioventricular (av) block is evidenced on the monitor, so an electrocardiogram (ekg) is performed in which blocked av is detected with electrical alteration due to tsv in the context of probable node disease.A transient pacemaker shirt placement and subsequent.Placement of a bipolar electrode was performed, which in spite of the multiple attempts it fails to capture, a new stimulation electrode is requested in which it is inserted through a pacemaker shirt with a capture at 25 cm without complications." patient current condition reported as fine.There was no report of serious injury or patient death.

Manufacturer Narrative

Qn# (b)(4).Teleflex did not receive the device for investigation therefore 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.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported "a second-degree atrioventricular (av) block is evidenced on the monitor, so an electrocardiogram (ekg) is performed in which blocked av is detected with electrical alteration due to tsv in the context of probable node disease.A transient pacemaker shirt placement and subsequent.Placement of a bipolar electrode was performed, which in spite of the multiple attempts it fails to capture, a new stimulation electrode is requested in which it is inserted through a pacemaker shirt with a capture at 25 cm without complications." patient current condition reported as fine.There was no report of serious injury or patient death.

• 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: 7843158
• MDR Text Key: 119499979
• Report Number: 3010532612-2018-00274
• 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: 08/09/2018

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?: No
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR