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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 Problems No Consequences Or Impact To Patient (2199); 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 mfr for eval. The investigation is currently underway. The info provided by bard represents all of the known info at this time. Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.
 
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 pt 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. The device returned was severly damaged severe bunching of the outer catheter and guidewire was noted. The outer catheter was torn and the inner guidewire lumen was protruding from the outer catheter. The guidewire was returned within the inner guidewire lumen and was protruding out the distal tip of the catheter. The guidewire was able to be removed once the bunching of the inner guidewire lumen was straightened out. 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. Per the reported event details, there were 15 events from the same user over a short period of time where the guidewire melted to the catheters during activation. The user's flowmate injector and generator were replaced with new units and the problem has not been experienced since. Therefore, it is possible that the flowmate injector and/or the generator contributed to the reported events however, based upon the available information the definitive root cause is unknown. The 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 RECANALIZATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
C.R.BARD, INC. (GFO)
289 bay road
queensbury NY 12804 2045
Manufacturer Contact
laura hintz
1625 west 3rd st.
tempe, AZ 85281
4808949515
MDR Report Key4905376
MDR Text Key14212857
Report Number2020394-2015-00994
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072776
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative,hea
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2015
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
Device Expiration Date03/31/2017
Device Catalogue NumberCRU14SA
Device Lot NumberGFZA3440
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/18/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
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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