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); Off-Label Use (1494); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).See mdr #3010532612-2019-00457 and (b)(4) for complaint involving the same patient and event.

Event Description

It was reported by the rn that blood was noted in the driveline tubing.The rn called the hotline and spoke to the clinical support specialist (css) and reported that there was blood in the current tubing.The patient was received from an outside hospital.The css explained that the blood in the tubing meant that there was a balloon rupture and the balloon needed to be removed.The rn stated that the physicians did not want to change out the intra-aortic balloon (iab).The iab was not inserted through the femoral artery.The css explained the possible complications if they continue to use the iab.The nurse stated that she would contact the physician.The css received another call from the facility, this time it was the fellow.He wanted assistance in switching the gas drive line tubing over to the maquet intra-aortic balloon pump (iabp).The css discussed with the dr.That if the iab was left in place that it could result in difficulties with removal and complications to the patient.The dr.Is aware of the possible complications to the patient but did not want to change out the catheter.The css explained how to change the gas drive tubing to the maquet pump.The iab was inserted off label.There was no report of injury or consequence to the patient.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore 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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: see mdr #3010532612-2019-00457 and tc # (b)(4), mdr #3010532612-2019-00435 and tc # (b)(4) for complaint involving the same patient and event.

Event Description

It was reported by the rn that blood was noted in the driveline tubing.The rn called the hotline and spoke to the clinical support specialist (css) and reported that there was blood in the current tubing.The patient was received from an outside hospital.The css explained that the blood in the tubing meant that there was a balloon rupture and the balloon needed to be removed.The rn stated that the physicians did not want to change out the intra-aortic balloon (iab).The iab was not inserted through the femoral artery.The css explained the possible complications if they continue to use the iab.The nurse stated that she would contact the physician.The css received another call from the facility, this time it was the fellow.He wanted assistance in switching the gas drive line tubing over to the maquet intra-aortic balloon pump (iabp).The css discussed with the dr.That if the iab was left in place that it could result in difficulties with removal and complications to the patient.The dr.Is aware of the possible complications to the patient but did not want to change out the catheter.The css explained how to change the gas drive tubing to the maquet pump.The iab was inserted off label.There was no report of injury or consequence to the patient.

• 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: 9526880
• MDR Text Key: 183768271
• Report Number: 3010532612-2019-00455
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• 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: 18F18L0001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1