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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Low Readings (2460)
Patient Problem Left Ventricular Dysfunction (1947)
Event Date 04/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The serial number was not reported. The serial number on the returned device is (b)(4). Returned for evaluation was a 30cc 8. 0fr iab fos in the supplied return kit. Within the sealed plastic bag, the central lumen was found significantly bent and potentially broken. Through further visual inspection, the central lumen was confirmed broken approximately 9. 0cm from the iab luer end. Blood was noted with the bladder membrane and short driveline tubing. The fos cabling was found cut at the bifurcate, and the remaining parts of the fos were not returned. After removing the bandage wrapped around the inflation lumen, two pressure caps were found connected to the inflation lumen. 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. The injection lumen and distal tip were capped to prevent the broken central lumen from causing a leak. The iab was submerged in water and leak tested. No leaks were detected on the bladder membrane. The bladder membrane passed functional testing. The device was unable to be pump tested due to the damaged state of the device upon return. See other remarks section. 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 augmentation difficulty is unable to be confirmed due to the damaged state of the catheter upon return. The device was not able to be pump tested, and as a result, the catheter could not be tested for augmentation difficulty. The device was returned with a broken central lumen, and blood was noted within the device. The root cause of the augmentation difficulty and broken central lumen is undetermined.
 
Event Description
It was reported via a hot line call. The registered nurse from the (ccu) cardiac care unit was calling to troubleshoot augmentation. The rn was asking how to increase augmentation. The pump (a2w) is pumping well, no alarms. Systolic pressure 128 augmented pressure 115 assisted map 86 unassisted 85. Pump is in autopilot mode 1:1 ratio pattern trigger. Patient in nsr (normal sinus rhythm) the rn reported the patient to be (b)(6) and has a 30cc iab in place. The clinical support specialist had the rn verify volume delivered on the screen is 30cc, the catheter size verified at the bifurcation as a 40cc. The css explained that the volume had been reduced which they sometimes do on bypass in surgery. The css had the rn change it back to full volume and the augmented pressure is now 139. The registered nurse reported all pressures looked much better. The css discussed other reasons for poor augmentation and the rn feels the patient is also vasodilated which they are treating. The css reminded the rn that volume changes require an order so she should verify this change with the doctor. The css provided her direct number should they have additional questions. The rn had no additional questions at this time. Inserted yesterday (b)(6) 2016. On 05/04/2016 update received per sales rep. The patient expired and the cardiologist stated the device did not cause the death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
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 Key5813913
MDR Text Key50194638
Report Number1219856-2016-00172
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
Remedial Action Recall
Type of Report Initial
Report Date 07/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2016
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F14G0046
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2014
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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