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

Model Number IPN039787

Device Problem Material Rupture (1546)

Patient Problem Death (1802)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after the insertion of the intra-aortic balloon (iab) the balloon ruptured 2 hours after.As a result, the iab was replaced and the same insertion site was used.A patient death occurred and the attending physician (lambros karagounis) made the medical judgement that the device did not cause or contribute to the patient's death.

Event Description

It was reported that after the insertion of the intra-aortic balloon (iab) the balloon ruptured 2 hours after.As a result, the iab was replaced and the same insertion site was used.A patient death occurred and the attending physician (lambros karagounis) made the medical judgement that the device did not cause or contribute to the patient's death.

Manufacturer Narrative

(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint that the "balloon ruptured" 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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• 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: 11147015
• MDR Text Key: 226026316
• Report Number: 3010532612-2021-00011
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: 01/31/2022
• Device Model Number: IPN039787
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20B0037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 95