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

Model Number IPN000254

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

Patient Problem Hematoma (1884)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was removed due to blood in the helium tubing.Per chart note, after removal there was a noted rupture of the balloon at the distal tip.After loss of pulse/flow in the right lower extremity, and a large hematoma, the patient was taken to surgery for vascular repair of the rfa.The surgical report documents severe tortuosity of the femoral/iliac artery with significant atherosclerotic disease.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, dried blood was confirmed within the iabc helium pathway.The iabc was returned with a damaged bladder, broken central lumen and additional damage noted from a second break in the central lumen near the distal tip of the bladder.The cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The returned iabc was too damaged to analyze further.The root cause how the blood entered in the helium pathway 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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon (iab) was removed due to blood in the helium tubing.Per chart note, after removal there was a noted rupture of the balloon at the distal tip.After loss of pulse/flow in the right lower extremity, and a large hematoma, the patient was taken to surgery for vascular repair of the rfa.The surgical report documents severe tortuosity of the femoral/iliac artery with significant atherosclerotic disease.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10482508
• MDR Text Key: 205292399
• Report Number: 3010532612-2020-00244
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19J0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1