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

Catalog Number IAB-S840C

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the guidewire was not able to be inserted.The staff noted that the guidewire was kinked.As a result, the device was replaced, and another attempt was made with a new guidewire successfully.There was no report of patient death, serious injury or complications.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the guidewire was not able to be inserted.The staff noted that the guidewire was kinked.As a result, the device was replaced, and another attempt was made with a new guidewire successfully.There was no report of patient death, serious injury or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint that the "guidewire was kinked" is confirmed based on the customer picture provided with the complaint report.The picture indicates that the guidewire was kinked.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8214039
• MDR Text Key: 131973085
• Report Number: 3010532612-2018-00409
• 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: 12/11/2018

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: 12/31/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F18A0001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1