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

Model Number IPN000263

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the doctor followed the instructions for use in the preparation and use of the product on the patient.There was a lot of resistance when the guidewire was passed.When the doctor removed the wire, he noticed the damaged tip.Then, the doctor passed the second guide wire through the introducer, also with resistance to pass the intra-aortic balloon (iab) by the wire and tried to introduce with the peel away, but due to the resistance the iab did not progress.The doctor removed the peel away and the iab did not pass either.The doctor tried the passage several times without success.As a result, the introducer was changed and the iab progressed without resistance and remained intact for use.There was no report of patient complications, serious injury, or death.

Manufacturer Narrative

Qn# (b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of iab insertion difficulty 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.Other remarks: corrected data: the report source was not checked off when the emdr initial was submitted.This has been corrected and the correct boxes were checked off.

Event Description

It was reported that the doctor followed the instructions for use in the preparation and use of the product on the patient.There was a lot of resistance when the guidewire was passed.When the doctor removed the wire, he noticed the damaged tip.Then, the doctor passed the second guide wire through the introducer, also with resistance to pass the intra-aortic balloon (iab) by the wire and tried to introduce with the peel away, but due to the resistance the iab did not progress.The doctor removed the peel away and the iab did not pass either.The doctor tried the passage several times without success.As a result, the introducer was changed and the iab progressed without resistance and remained intact for use.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10854247
• MDR Text Key: 218229553
• Report Number: 3010532612-2020-00346
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

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: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F20B0022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1