MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the package was opened, the doctor noted that the intra-aortic balloon (iab) was a bit bent.During insertion, the doctor noted that the spring wire guide could not pass through the central cavity of the balloon.As a result, the balloon was removed, and another attempt was made with a new balloon successfully.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).The reported compliant that the "iab kinked, guidewire could not pass" is confirmed.Two kinks were noted on the iab during the complaint investigation, and the guidewire could not successfully pass through the iab.The root cause of this 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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that when the package was opened, the doctor noted that the intra-aortic balloon (iab) was a bit bent.During insertion, the doctor noted that the spring wire guide could not pass through the central cavity of the balloon.As a result, the balloon was removed, and another attempt was made with a new balloon successfully.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8248027
• MDR Text Key: 133065200
• Report Number: 3010532612-2018-00419
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• 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: 12/21/2018

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: 01/31/2020
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F18B0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 88