MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the staff found blood-like material in the gas driving tube.As a result, the intra-aortic balloon (iab) catheter was removed and an alternative source was used for therapy.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 of blood in helium pathway is confirmed.The iab bladder had a full thickness abrasion, which caused blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected during functional testing.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.Other remarks: additional information was received.It was reported that the patient had heavy calcification of artery, so the user had difficulty of inserting the iab in this patient.For the above reason, there were some fine pinholes found on the balloon.The user confirmed the condition of the iab and iabp every a couple of hours, but failed to prevent blood backflow in the iabp.As a result, the iab and iabp were immediately removed but the therapy with pcps was continued and consequently the therapy was successfully finished.

Event Description

It was reported that the staff found blood-like material in the gas driving tube.As a result, the intra-aortic balloon (iab) catheter was removed and an alternative source was used for therapy.There was no report of patient complication or serious injury and death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8387780
• MDR Text Key: 137739389
• Report Number: 3010532612-2019-00044
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• 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: 02/14/2019

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: 06/30/2020
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F18G0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1