MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000262

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem Death (1802)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was in use a leak was found during inflation, and blood was noted in the balloon.The patient's blood vessels are tortuous when the iab was placed.As a result, the iab was replaced, and the same insertion site was used.A patient death was reported.Director (b)(6) made the medical judgement that the device did not cause, or contribute to the patient's death.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use a leak was found during inflation and blood was noted in the balloon.The patient's blood vessels are tortuous when the iab was placed.As a result, the iab was replaced and the same insertion site was used.A patient death was reported.Director guocai cai made the medical judgement that the device did not cause or contribute to the patient's death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, numerous punctures to the bladder, consistent with contact from a sharp object, were found on the bladder membrane which can cause the helium loss alarm and could allow blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the leaks on the bladder is undetermined.A potential cause is customer handling.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: it was noticed that a misspelling was found in section b7.The correction has been made and now reads as "acute myocardial infarction".

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10635130
• MDR Text Key: 209999143
• Report Number: 3010532612-2020-00286
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F19L0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR