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

Catalog Number CRE14S

Device Problems Flushing Problem (1252); Overheating of Device (1437); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2016

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 return of the device is pending.The investigation is currently underway.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 the out of body test process, the recanalization catheter allegedly could not be flushed.It was further reported that the catheter allegedly became hot to the touch; therefore, the heath care provider (hcp) exchanged the recanalization catheter with another and performed the procedure.There was no patient contact.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.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 that has been reported for this corporate lot number to date.Visual/microscopic inspection: the sample appeared to be clean.The core wire was intact.The distal tip was examined under microscopic magnification (20x) and no anomalies were noted.No anomalies were noted along the length of the catheter.Functional/performance evaluation: the patency of the guidewire lumen was tested with an in-house 0.014¿ guidewire and passed without issue.The device was attached to the transducer of the in-house generator.An in-house flowmate was used to flush the device with saline.The device was able to produce vibrations throughout the entire length of the catheter.Misting was observed coming out from the distal tip, indicating that the device was vibrating properly.The distal tip of the catheter was pressed against one end of a 5mm plaster tile, and was able to penetrate the tile with no issues.The catheter was activated for a total of 5 minutes and no overheating or melting of the catheter was observed.No anomalies were noted to the catheter during activation.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 investigation was unconfirmed, as the catheter was able to successfully vibrate and mist for five minutes with no overheating observed during functional testing.The definitive root cause could not be determined based upon available information.It was unknown whether procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: set up: - set the irrigation system to 0.3ml/sec (18 ml/min) and switch irrigation system ¿on¿.Allow irrigation to flow for approximately 10-15 seconds to purge all air from the crosser catheter irrigation lumen.- note: a constant flow should be observed at the tip of the crosser catheter.If irregular or no flow is observed, check irrigation system for proper function.If irrigation system is not functioning properly discard crosser catheter and replace with another.- hold the crosser catheter at the distal tip in one hand and switch crosser generator ¿on¿.Verify the crosser generator is ¿on¿ by observing front panel display.Once power to crosser generator has been confirmed, and the irrigation is flowing, depress foot switch for 3-5 seconds to test the function of system.Transmission of energy can be observed at the tip of the catheter.Warnings and precautions: - 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.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 the out of body test process, the recanalization catheter allegedly could not be flushed.It was further reported that the catheter allegedly became hot to the touch; therefore, the heath care provider (hcp) exchanged the recanalization catheter with another and performed the procedure.There was no patient contact.

• 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: 6205239
• MDR Text Key: 63330488
• Report Number: 2020394-2016-01205
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801741125420
• UDI-Public: (01)10801741125420(17)180430(10)GFAP2141
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: CRE14S
• Device Lot Number: GFAP2141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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