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

Model Number IPN000254

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: see mdr# 3010532612-2020-00274 (tc1900079475) as the reports are related to the same patient.

Event Description

It was reported that when the intra-aortic balloon (iab) the staff experienced continuous helium loss alarm and suspected a rupture.As a result, the iab was removed and a second iab was used.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the intra-aortic balloon (iab) the staff experienced continuous helium loss alarm and suspected a rupture.As a result, the iab was removed and a second iab was used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab leak suspected is not able to be confirmed.The product was not returned for investigation.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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00274 (b)(4) as the reports are related to the same patient.

• 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: 10599626
• MDR Text Key: 208947704
• Report Number: 3010532612-2020-00275
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1