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

Model Number IPN000263

Device Problem Failure to Advance (2524)

Patient Problem Death (1802)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: see mdr# 3010532612-2021-00005 ((b)(4)) as the report is related to the same patient.

Event Description

It was reported that during insertion, the guide wire was not passing through the central lumen of the intra-aortic balloon (iab), as the staff stated that "there was an obstruction".As a result, another iab was used.There was a report of patient death.Dr.(b)(6) made the medical judgement that the device did not cause or contribute to patient's d eath.

Event Description

It was reported that during insertion, the guide wire was not passing through the central lumen of the intra-aortic balloon (iab), as the staff stated that "there was an obstruction".As a result, another iab was used.There was a report of patient death.Dr.(b)(6) the medical judgement that the device did not cause or contribute to patient's d eath.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.During the investigation, there was immediate resistance noted upon passing the guidewire through the iabc central lumen.The guidewire insertion difficulty was occurring within the bifurcate.Additionally, a cross-over leak was confirmed between the helium pathway and central lumen, however there was no obvious central lumen break and the crossover site potentially occurred within the bifurcate.A non-conformance has been initiated to further investigate the issue.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# 3010532612-2021-00005 (b)(4)) as the report is related to the same patient.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11202228
• MDR Text Key: 227947983
• Report Number: 3010532612-2021-00006
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• 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: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F20B0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR