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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. CROSSER CATHETER 14S RX RECANALIZATION CATHETER Back to Search Results
Catalog Number CRU14SA
Device Problem Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2015
Event Type  Malfunction  
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. This is the only complaint reported to date for corporate lot number gfzf3633. Visual inspection: the sample was not returned; therefore, visual inspection could not be performed. Functional/performance evaluation: the sample was not returned; therefore, functional evaluation and performance evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: one photo was returned and reviewed. The photo shows what appears to be a crosser catheter with a guidewire inserted. The portion of the guidewire that is not inserted into the catheter is spiraled in appearance. The guidewire lumen appears to have been partially pulled out of the catheter. Based upon the photo provided, melting of the crosser catheter to the guidewire cannot be confirmed. Conclusion: the complaint investigation is inconclusive for the catheter melting to the guidewire. The definitive root cause could not be determined based upon the available information. Labeling review: the crosser recanalization catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. 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 during use in the right tibial, the recanalization catheter melted onto the guide wire. Another recanalization catheter was used to complete the procedure. There was no reported patient injury.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. The lot met all release criteria. Visual inspection:the sample was returned. The catheter was returned with bunching noted along the length of the catheter. The outer catheter was torn at the rapid exchange junction. The guidewire was returned within the inner guidewire lumen, but was not protruding out the distal tip of the crosser. The guidewire was returned severely bunched inside the inner guidewire lumen. The proximal end of the guidewire coming out the rapid exchange junction was spiraled in appearance. 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 and guidewire was straightened out and the guidewire was able to be removed without issue. The guidewire and catheter were examined under a microscope and no obvious signs of melting were observed. No further functional testing could be performed due to the poor sample condition. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: no additional images/photos were provided; therefore, no additional reviews were performed. 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. The definitive root cause could not be determined based upon the available information. Labeling review: the current crosser recanalization catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. 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 during use in the right tibial, the recanalization catheter allegedly melted onto the guide wire. Another recanalization catheter was used to complete the procedure. There was no reported patient injury.

 
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Brand NameCROSSER CATHETER 14S RX
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 Key5108970
MDR Text Key26938636
Report Number2020394-2015-01642
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,Followup
Report Date 08/31/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2017
Device Catalogue NumberCRU14SA
Device LOT NumberGFZF3633
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/17/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/13/2015
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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