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

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.

• Brand Name: CROSSER CATHETER 14S RX
• Type of Device: RECANALIZATION 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 Key: 5108970
• MDR Text Key: 26938636
• Report Number: 2020394-2015-01642
• 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: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFZF3633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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
• Patient Age: 67 YR
• Patient Weight: 90