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Catalog Number CRU14SA
Device Problems Fracture (1260); Melted (1385); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
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 patient injury.

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 not been returned to the manufacturer for evaluation. The investigation is currently underway.

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.

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 investigation is inconclusive, as the sample was not returned for evaluation. Per the reported event details, there were (b)(4) events from the same user over a short period of time where the guidewires 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.

Manufacturer Narrative

Visual/microscopic inspection: a complete core wire fracture and catheter detachment was noted at the distal end of the catheter. The outer catheter was stretched at the location of the detachment, likely indicating that excessive force contributed to the detachment. The remaining core wire proximal to the strain relief measured approximately 142. 6cm. This indicates that approximately 3. 4cm of the catheter detached. Functional/performance evaluation: no functional testing could be performed due to the catheter detachment. Medical records review: no medical records have been made available to the manufacturer. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is confirmed for a complete core wire fracture and a catheter detachment, as the distal portion of the catheter was detached and not returned for evaluation. 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. 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 ifu (instructions for use) states: warnings and precautions: for the crosser catheter 14s flush the guidewire lumen of the crosser catheter using a standard 10ml syringe with heparinized saline. Do not activate the crosser recanalization system without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. Always use refrigerated saline. When manipulating the crosser catheter, the catheter shaft may become warm to the touch. A warm feeling is normal, however, if the catheter shaft becomes hot discontinue use immediately and withdraw from patient. Once removed from the patient confirm that irrigation is flowing. (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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Manufacturer (Section D)
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
289 bay road
queensbury NY 12804 2045
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
MDR Report Key4905404
MDR Text Key6071330
Report Number2020394-2015-01001
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,COMPANY REPRESENTATIVE,HEA
Reporter Occupation
Type of Report Initial,Followup,Followup,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 EXPIRATION Date02/28/2017
Device Catalogue NumberCRU14SA
Device LOT NumberGFYL3037
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial