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

Catalog Number IAB-05840-LWS

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was removed from the tray, and there was a kink in the central lumen of the iab.The md opted to insert the iab.It was reported that the md had a very difficult time getting the iab over the wire, and was only able to insert it part of the way.The md then opted to remove the iab, and replace it with a second iab.The clinical support specialist (css) did discuss insertion technique and removal of the iab from the tray.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 kinked is confirmed.Upon visual inspection, two bends were noted to the iab central lumen.Upon inserting a guidewire, resistance was experienced at the locations of the bends.The bends on the iab central lumen can result in guidewire insertion difficulty.The root cause of the bends is undetermined.A potential cause is a result from 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 risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) was removed from the tray, and there was a kink in the central lumen of the iab.The md opted to insert the iab.It was reported that the md had a very difficult time getting the iab over the wire, and was only able to insert it part of the way.The md then opted to remove the iab, and replace it with a second iab.The clinical support specialist (css) did discuss insertion technique and removal of the iab from the tray.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8864324
• MDR Text Key: 156605721
• Report Number: 3010532612-2019-00243
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18F0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/06/2019
• Patient Sequence Number: 1