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

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the intra-aortic balloon (iab) placement progressed smoothly with no difficulty via the right femoral artery on (b)(6) 2017 at 1300.The patient was transferred to the intensive care unit (icu) where iab pumping continued.At about 0030hrs on (b)(6) 2017 the intra-aortic balloon pump (iabp) alarmed and stopped pumping.Pumping was commenced again the alarm was activated again and pumping ceased again.At this stage the presence of blood was noticed in the helium gas line.The medical doctor (md) was called and she advised the staff to remove the balloon catheter.The patient returned to the cath lab in the morning to receive another iab.Prior to the procedure an aorta-gram was done and it showed significant narrowing of the aorta above the renal arteries.It was decided not to place another catheter at this time.There was a reported delay/interruption in therapy.No reported patient death or injuries.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway.The root cause of the broken fiber 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 will continue to monitor for developing trends.

Event Description

It was reported the intra-aortic balloon (iab) placement progressed smoothly with no difficulty via the right femoral artery on (b)(6) 2017 at 1300.The patient was transferred to the intensive care unit (icu) where iab pumping continued.At about 0030hrs on (b)(6) 2017 the intra-aortic balloon pump (iabp) alarmed and stopped pumping.Pumping was commenced again the alarm was activated again and pumping ceased again.At this stage the presence of blood was noticed in the helium gas line.The medical doctor (md) was called and she advised the staff to remove the balloon catheter.The patient returned to the cath lab in the morning to receive another iab.Prior to the procedure an aorta-gram was done and it showed significant narrowing of the aorta above the renal arteries.It was decided not to place another catheter at this time.There was a reported delay/interruption in therapy.No reported patient death or injuries.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6380785
• MDR Text Key: 69211814
• Report Number: 3010532612-2017-00004
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16G0038
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1