MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05840-LWS

Device Problems Complete Blockage (1094); No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that they were unable to obtain arterial pressures from the central lumen of the intra-aortic balloon (iab).The rn stated changing the transducer and cables.The clinical support specialist described that they could slave the line from the anesthesia monitor, or use an alternate arterial line for monitoring.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab ap waveform poor signal is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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.No further action required at this time.

Event Description

It was reported by the rn that they were unable to obtain arterial pressures from the central lumen of the intra-aortic balloon (iab).The rn stated changing the transducer and cables.The clinical support specialist described that they could slave the line from the anesthesia monitor, or use an alternate arterial line for monitoring.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8687571
• MDR Text Key: 147616496
• Report Number: 3010532612-2019-00182
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2019

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: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1