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 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on insertion of the intra-aortic balloon (iab) the dilator with the sheath was inserted into the patient's femoral artery, the md was not able to insert. The blood vessel is sufficiently dilated. Therefore the dilator was removed, and the doctor found the end of the dilator was damage. As a result, a new set was used. The patient outcome reported as fine. There was no report of patient complication or serious injury and death.

Event Description

It was reported that on insertion of the intra-aortic balloon (iab) the dilator with the sheath was inserted into the patient's femoral artery, the md was not able to insert. The blood vessel is sufficiently dilated. Therefore the dilator was removed, and the doctor found the end of the dilator was damage. As a result, a new set was used. The patient outcome reported as fine. There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4). Teleflex received the device for investigation. The reported complaint that the dilator tip was damaged is confirmed by visual inspection of the returned samples. The appearance of the dilator tip damage is an inconsistent diameter with indents or pinches around the tip opening. The root cause of the damaged dilator tip 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. This will be monitored for any developing trends. No further action required at this time.

• 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: 8544568
• MDR Text Key: 142914544
• Report Number: 3010532612-2019-00109
• 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: 04/01/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2020
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F18B0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No