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

Catalog Number IAB-S840C

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Death (1802); Renal Disease, End Stage (2039); Perforation of Vessels (2135)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted after puncture, it was noted that the balloon was kinked at the front end of the blood vessel which caused damage of the front end of the blood vessel. The blood vessel was repaired by the vascular surgery doctor. As a result, the catheter was removed, and a second attempt was made successfully with a new catheter. Patient outcome reported as fine. There was no report of patient death.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted after puncture, it was noted that the balloon was kinked at the front end of the blood vessel which caused damage of the front end of the blood vessel. The blood vessel was repaired by the vascular surgery doctor. As a result, the catheter was removed, and a second attempt was made successfully with a new catheter. Patient outcome reported as fine. There was no report of patient death.

Manufacturer Narrative

(b)(4). Teleflex received the device for investigation. The reported complaint of iab kinked is not able to be confirmed. No kinks, bends or damage was noted on the returned iab during the complaint investigation. The returned device passed visual and functional test specifications. The root cause of the complaint is undetermined. Potential causes are patient condition and insertion technique. No further action required at this time. 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. Other remarks: additional information received. On (b)(6) 2019, the balloon was inserted after puncture, then the balloon was found kinked at the front end of the blood vessel, which caused the damage of the front end of the blood vessel. Then the blood vessel was repaired by the vascular surgery doctor. Then the new catheter was re-inserted successfully at the opposite site. Some days later, the patient died as his physical condition- renal failure. The dr. (b)(6) judged it was not our device which caused the death, as the death was caused by the patient's physical condition.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8349738
• MDR Text Key: 136467506
• Report Number: 3010532612-2019-00024
• Device Sequence Number: 1
• Product Code: DSP
• 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: 01/28/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17L0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No