MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETER

Catalog Number CREO14S

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that the recanalization catheter was allegedly unable to advance to the left common iliac artery; therefore, the health care provider (hcp) retracted the device.During retraction under fluoroscopy, the hcp allegedly identified a plastic like material at the tip of the recanalization catheter.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were 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/microscopic inspection: a strand of unknown material approximately 7.7cm in length was observed to be caught on the distal metal tip.Kinks and bunching was noted to the outer catheter.The tip was examined under microscopic magnification (25x) and no anomalies were noted.Functional/performance evaluation: the patency of the guidewire lumen was tested with an in-house 0.014¿ guidewire.The guidewire was loaded through the hub and but unable to advance past 130.8cm from the distal tip.The guidewire was then loaded through the distal tip but was unable to be advanced past 47.0cm from the hub.The outer catheter was removed in the area.It was observed that the guidewire lumen was twisted around the core wire.Due to the material twisting, the guidewire could not be loaded through the catheter.Further functional testing could not be performed due to the returned condition of the device.As received one crosser catheter with the presence of a foreign material embedded under the crosser tip.The crosser catheter was reviewed under approximately 10x magnification.Foreign material was confirmed to be embedded under the crosser tip.There were no noted defects in the tip or shaft area where the foreign material was noted.No missing materials or defects were noted with the crosser catheter.The foreign material most likely originated from other devices used during the procedure, but without the return of ancillary devices and components used during the procedure, the source of the foreign material cannot be determined.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 device was returned.Based on the returned sample the investigation is confirmed for foreign material as an unknown material was embedded under the distal metal tip.The investigation is confirmed for device-device incompatibility and material twisting as an in-house guidewire could not be fully advanced through the catheter due to the guidewire lumen twisting.The investigation is inconclusive for failure to advance as functional testing could not be performed due to the returned condition of the device.It is possible that the foreign material was a coating from an ancillary device used in the procedure.However the origin of the foreign material could not be determined based on the available information.The guidewire compatibility issues as a result of a twisted guidewire lumen could possibly have contributed to the failure to cross the lesion.However the definitive root cause could not be determined based upon the available information.It is unknown if procedural issues during the attachment of the catheter to the transducer contributed to the twisted catheter and outer catheter separation from the distal tip.Labeling review: the current ifu (instructions for use) states: warnings and precautions: prior to use, the packaging and product should be inspected for signs of damage.Never use damaged product or product from a damaged package.When using the crosser in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the crosser catheter tip.Kinking or prolapse of the tip could cause catheter breakage and/or malfunction.Interventional use: slowly advance the catheter tip through the lesion.Apply steady, constant pressure so the tip of the catheter is engaged to the lesion.Upon successful recanalization of the lesion, advance the guidewire distal to the lesion and then withdraw the crosser catheter 14p, 14s, or 18.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 was allegedly unable to advance to the left common iliac artery; therefore, the health care provider (hcp) retracted the device.During retraction under fluoroscopy, the hcp allegedly identified a plastic like material at the tip of the recanalization catheter.There was no reported patient injury.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6187633
• MDR Text Key: 62790452
• Report Number: 2020394-2016-01182
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801741125468
• UDI-Public: (01)10801741125468(17)180930(10)GFAV3378
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: CREO14S
• Device Lot Number: GFAV3378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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