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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Fluid 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.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- 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 Key6380785
MDR Text Key69211814
Report Number3010532612-2017-00004
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16G0038
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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