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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CATHETER 14S RX

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BARD PERIPHERAL VASCULAR, INC. CROSSER CATHETER 14S RX Back to Search Results
Catalog Number CRU14SA
Device Problems Melted (1385); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/09/2015
Event Type  Malfunction  
Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The investigation of the reported event is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. 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 after successfully crossing a lesion in the anterior tibial, the recanalization catheter would not retract/release from the guidewire. The recanalization catheter and guidewire were removed together and access through the lesion was lost. The recanalization catheter appeared to be melted onto the guidewire. Another catheter and guidewire were used to cross the lesion and complete the treatment of the vessel. There was no reported patient injury.

 
Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Visual inspection: one crosser catheter with a guidewire was returned for evaluation. The catheter was returned with bunching of the outer catheter noted near the distal end of the catheter. The outer catheter was torn at the rapid exchange junction. The guidewire was returned within the inner guidewire lumen and was protruding out the distal tip of the crosser. Functional/performance evaluation: an attempt was made to retract the guidewire from the catheter. However, the guidewire was unable to be retracted. The bunching of the catheter was straightened out and the guidewire still could not be retracted. No further functional testing could be performed due to the poor sample condition. The guidewire and catheter were examined under a microscope and no obvious signs of melting were observed. Conclusion: the investigation is inconclusive, as functional testing could not be performed due to the poor sample condition and no obvious signs of melting were found on the catheter or the guidewire. The guidewire was returned stuck within the catheter;therefore, it is possible that the user perceived the guidewire becoming stuck in the guidewire lumen as the catheter "melting" to the guidewire. Labeling review: the current crosser instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.

 
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Brand NameCROSSER CATHETER 14S RX
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804 2045
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key4993253
MDR Text Key24302409
Report Number2020394-2015-01295
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 PHYSICIAN
Type of Report Initial,Followup
Report Date 07/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2017
Device Catalogue NumberCRU14SA
Device LOT NumberGFZE3345
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/20/2015
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2015
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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