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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 Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sample was discarded and will not be returned for investigation.
 
Event Description
It was reported via a hot line call. The rn from the ccu called the clinical support specialist and stated that during an insertion, the iab was inserted normally via the femoral artery without difficulty. After placement the guidewire would not withdraw from the catheter. The catheter and sheath were removed and a second iab was inserted without difficulty. The patient was then supported on the iabp. The rn told the css that this was not a current incident.
 
Manufacturer Narrative
(b)(4) no product was returned for evaluation. 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. Conclusion: the reported complaint of swg removal difficult is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported via a hot line call. The rn from the ccu called the clinical support specialist and stated that during an insertion, the iab was inserted normally via the femoral artery without difficulty. After placement the guidewire would not withdraw from the catheter. The catheter and sheath were removed and a second iab was inserted without difficulty. The patient was then supported on the iabp. The rn told the css that this was not a current incident.
 
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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 Key5746611
MDR Text Key48098799
Report Number1219856-2016-00136
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
Type of Report Initial,Followup
Report Date 06/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16B0036
Other Device ID Number0080190200724
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2016
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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