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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER RECANALIZATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. CROSSER RECANALIZATION CATHETER Back to Search Results
Catalog Number CRU14SA
Device Problem Melted (1385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A manufacturing review could not be performed as the lot number is unknown. The device has not been returned to the manufacturer for evaluation. The investigation is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the recanalization catheter melted to the guide wire after approximately two minutes of activation in the tibial. The catheter and wire were removed together without incident. There was no reported patient injury.
 
Manufacturer Narrative
A complete manufacturing review could not be conducted as the lot number is unknown. The investigation is inconclusive, as the sample was not returned for evaluation. Per the reported event details, there were 15 events from the same user over a short period of time where the guidewires melted to the catheters during activation. The user's flowmate injector and generator were replaced with new units and the problem has not been experienced since. Therefore, it is possible that the flowmate injector and/or the generator contributed to the reported events. However, based upon the available information the definitive root cause is unknown.
 
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Brand NameCROSSER RECANALIZATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay rd.
queensbury NY 12804 204
Manufacturer Contact
1625 west 3rd st.
tempe, AZ 85281
4808949515
MDR Report Key4905382
MDR Text Key13770546
Report Number2020394-2015-01002
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/01/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCRU14SA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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