MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000252

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This complaint was received via medwatch report (b)(4).It was reported that debris was noted within the intra-aortic balloon (iab) helium supply line.Black dots were seen inside the helium tubing concerning for blood from balloon puncture.The intra-aortic balloon pump (iabp) device was not alarming and patient's hemodynamics not affected at the time of event.The iabp dropped to 1:4.An attempt left iab removal with sheath over long guidewire with the intention of replacing sheath, but resistance was met with removal of the iab/sheath unit with distal third of balloon still in the femoral vessel.This was ultimately removed by the doctor.As a result, a new iab was placed in the right femoral artery.

Event Description

This complaint was received via medwatch report (b)(4).It was reported that debris was noted within the intra-aortic balloon (iab) helium supply line.Black dots were seen inside the helium tubing concerning for blood from balloon puncture.The intra-aortic balloon pump (iabp) device was not alarming and patient's hemodynamics not affected at the time of event.The iabp dropped to 1:4.An attempt left iab removal with sheath over long guidewire with the intention of replacing sheath, but resistance was met with removal of the iab/sheath unit with distal third of balloon still in the femoral vessel.This was ultimately removed by the doctor.As a result, a new iab was placed in the right femoral artery.

Manufacturer Narrative

Qn#(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab: blood in helium pathway is not able to be confirmed.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 revived risk.This will be monitored for any developing trends.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10700804
• MDR Text Key: 212472063
• Report Number: 3010532612-2020-00311
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: IPN000252
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F18L0011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR