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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 Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event involved a patient in the cath lab the iab was inserted and soon after putting in the body the catheter clotted. According to the customer "it would not work at all. " as a result the iab was removed and replaced successfully. There was a delay in iabp therapy however no harm caused to the patient. There was no reported patient death, injury or complications. The patient outcome is listed as "survived".
 
Manufacturer Narrative
(b)(4). The sample was return the one-way valve was connected and tethered to the short driveline tubing. The iab hemostasis cuff was connected to the cathgard. The bladder was loosely wrapped. Dried blood was noted on the exterior of the bladder, outer lumen, cathgard, bifurcate and one-way valve. The fos connector and cal key were examined. The gray fos connecter was recessed in the housing and both retaining tabs were intact. The center post of the fos was centered. The blue clamshell housing was examined and no damage was noted. The cal key was intact. The one-way valve was tested and passed. A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint of central lumen occluded is confirmed. Initially the central lumen failed aspiration and flush testing. Upon inserting the guidewire, blood exited the central lumen. Aspiration and flushing were successfully completed after the guidewire test. The blood built up in the central lumen may have occurred from not maintaining a patency of the arterial line.
 
Event Description
It was reported that the event involved a patient in the cath lab the iab was inserted and soon after putting in the body the catheter clotted. According to the customer "it would not work at all. " as a result the iab was removed and replaced successfully. There was a delay in iabp therapy however no harm caused to the patient. There was no reported patient death, injury or complications. The patient outcome is listed as "survived".
 
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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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5990094
MDR Text Key56018617
Report Number1219856-2016-00212
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2016
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 Number18F16G0019
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2016
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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