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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 Problem Melted (1385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the device has been provided. A review of the device history records is currently being performed. The device has 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 allegedly melted to the guide wire in the sfa. It was further reported that the catheter and guide wire were removed together without incident. The procedure was said to have been completed with another support catheter. 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: the sample was returned. The catheter was returned with bunching of the outer catheter noted along the length of the catheter. The guidewire segment was protruding out of the rapid exchange junction and was bent in appearance. The rest of the guidewire was detached and not returned. The guidewire was not 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 could not be removed. The catheter was placed in the x-ray machine. The guidewire was observed to be twisted around the core wire. The guidewire lumen was removed from the catheter and was noted to be bunched in appearance. The guidewire and inner guidewire lumen of the crosser were examined and no signs of melting were observed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the investigation is inconclusive for melting, 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 investigation is confirmed for a twisted guidewire lumen. It is unknown whether the twisted guidewire lumen contributed to the guidewire becoming stuck in the guidewire lumen. 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: specific warnings, precautions and directions for use of the crosser recanalization catheter are included in the current instructions for use (ifu).

 
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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 Key4943776
MDR Text Key22572596
Report Number2020394-2015-01213
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 06/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2017
Device Catalogue NumberCRU14SA
Device LOT NumberGFZ0140
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/10/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/18/2015
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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