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

Model Number IPN000262

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).See mdr# 3010532612-2020-00368 ((b)(4)) as the report is related to the same patient.

Event Description

It was reported that the first intra-aortic balloon (iab) was exchanged and a second iab was used and the second iab dispersed during insertion, which made it difficult to insert.As a result, another iab was used and inserted using the same insertion site.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 unwrapped prematurely is not able to be confirmed based on the returned state of the device.Upon return, the iab bladder was fully unwrapped.The returned iab passed functional testing.The packaging retention sleeve was noted on the bladder membrane upon receipt, which indicates a potential that the catheter was not prepped per the instructions for use (ifu) and can result in damage to the catheter.There was also blood found within the central lumen, indicating the user potentially attempted to insert a fully unwrapped balloon.An in-service has been requested to reiterate the ifu, including the appropriate method for catheter prep/removal from its packaging and the risks of inserting a balloon without pulling/maintaining a vacuum.The root cause of the complaint is undetermined.A potential cause is user related.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# 3010532612-2020-00368 ((b)(4)) as the report is related to the same patient.

Event Description

It was reported that the first intra-aortic balloon (iab) was exchanged and a second iab was used and the second iab dispersed during insertion, which made it difficult to insert.As a result, another iab was used and inserted using the same insertion site.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10856073
• MDR Text Key: 219496316
• Report Number: 3010532612-2020-00354
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F20B0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.; NI.