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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  
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 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.

 
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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
laura hintz
1625 west 3rd st.
tempe, AZ 85281
4808949515
MDR Report Key4905412
MDR Text Key18266710
Report Number2020394-2015-01007
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/05/2015
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 HEALTH PROFESSIONAL
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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