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

Catalog Number CRU14SA

Device Problems Melted (1385); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

No medical records or no 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 investigation of the reported event is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 after successfully crossing a lesion in the anterior tibial, the recanalization catheter would not retract/release from the guidewire.The recanalization catheter and guidewire were removed together and access through the lesion was lost.The recanalization catheter appeared to be melted onto the guidewire.Another catheter and guidewire were used to cross the lesion and complete the treatment of the vessel.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: one crosser catheter with a guidewire was returned for evaluation.The catheter was returned with bunching of the outer catheter noted near the distal end of the catheter.The outer catheter was torn at the rapid exchange junction.The guidewire was returned within the inner guidewire lumen and was 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 was unable to be retracted.The bunching of the catheter was straightened out and the guidewire still could not be retracted.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.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;therefore, it is possible that the user perceived the guidewire becoming stuck in the guidewire lumen as the catheter "melting" to the guidewire.Labeling review: the current 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.

• Brand Name: CROSSER 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 Key: 4993253
• MDR Text Key: 24302409
• Report Number: 2020394-2015-01295
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFZE3345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2015
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1