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

Model Number IPN039792

Device Problem Fluid/Blood Leak (1250)

Patient Problem Vascular Dissection (3160)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that at the end of the procedure, blood was found in the helium circuit.An attempt was made to remove the catheter which got stuck in the femoral artery at the entry hole.The retraction caused a lesion in the artery requiring tamponade and occlusion of the upstream femoral artery.The issue was resolved through surgery to suture the lesion.According to the information available, the surgical intervention was successful.Another catheter was not inserted.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the 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 risk.This will be monitored for any developing trends.

Event Description

It was reported that at the end of the procedure, blood was found in the helium circuit.An attempt was made to remove the catheter which got stuck in the femoral artery at the entry hole.The retraction caused a lesion in the artery requiring tamponade and occlusion of the upstream femoral artery.The issue was resolved through surgery to suture the lesion.According to the information available, the surgical intervention was successful.Another catheter was not inserted.

• 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: 12202828
• MDR Text Key: 262654174
• Report Number: 3010532612-2021-00222
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN039792
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21D0006
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR