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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 CRUO14PA
Device Problem Melted (1385)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

No hospital/medical records or 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 device has been returned to the manufacturer for evaluation. The investigation of the reported event 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 allegedly melted to the guide wire after a few seconds of activation. It was further reported that the catheter and wire were removed together without incident. Another catheter was used to complete the procedure. There was no reported patient injury.

 
Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported for this lot number and issue to date. Visual/microscopic inspection: crosser catheter with a 0. 014" guidewire inserted through the catheter was returned with product packaging and label. The catheter was returned with bunching of the outer catheter noted 2. 8cm from the distal tip. The distal end of the guidewire was not protruding out the distal tip of the catheter. No other anomalies were noted along the length of the catheter. 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. Dried blood was present inside the guidewire lumen, likely contributing to the guidewire not being able to be removed. The catheter and guidewire were soaked in water in an attempt to remove the guidewire. The guidewire was still unable to be removed from the catheter. The outer catheter was stripped and the inner guidewire lumen was cut at multiple locations along the length of the catheter. After cutting the inner guidewire lumen, the guidewire was able to be removed from the catheter. Dried blood was present on the guidewire once removed. 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. Medical records review_ image/photo review: medical records were not provided. No images or photos were provided. 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. It is possible that the user perceived the guidewire becoming stuck in the guidewire lumen as the catheter "melting" to the guidewire. The definitive root cause could not be determined based upon the available information. Labeling review: the current crosser cto recanalization catheters instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. (b)(4). 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
Type of DeviceRECANALIZATION CATHETER
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
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5160654
MDR Text Key29034386
Report Number2020394-2015-01730
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK091119
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device Catalogue NumberCRUO14PA
Device LOT NumberGFYL3041
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/30/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2015
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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