MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000252

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the hospital staff that during insertion, the intra-aortic balloon (iab) was noted kinked.As a result, the iab was removed and a new iab was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

Event Description

It was reported by the hospital staff that during insertion, the intra-aortic balloon (iab) was noted kinked.As a result, the iab was removed and a new iab was inserted at the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab kinked is confirmed.A kink to the central lumen was noted during the visual inspection of the returned iab catheter, and a guidewire could not pass successfully through the central lumen during functional testing.The root cause of the kink is undetermined, but 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 revised risk.This will be monitored for any developing trends.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11792583
• MDR Text Key: 249677240
• Report Number: 3010532612-2021-00128
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: IPN000252
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F20G0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1