MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problems Failure to Read Input Signal (1581); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: see mdr# 3010532612-2019-00317 and (b)(4) as the report is related to the same patient.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted at the same insertion site after the first iab was removed.The same sequence of events occurred.Fiber optic zeroed prior to insertion and then the signal was lost.As a result, doctor removed the second iab and chose to discontinue therapy.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 iab fos signal lost is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.The root cause of the broken fiber 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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2019-00317 and (b)(4) as the report is related to the same patient.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted at the same insertion site after the first iab was removed.The same sequence of events occurred.Fiber optic zeroed prior to insertion and then the signal was lost.As a result, doctor removed the second iab and chose to discontinue therapy.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8959658
• MDR Text Key: 156585315
• Report Number: 3010532612-2019-00318
• 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: 08/15/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F18K0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1