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

Catalog Number CRES6

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer the lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.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 the recanalization catheter allegedly overheated.There was no patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/ inspection: the sample was returned used.The core wire was intact.There were no anomalies noted at the tip or along the length of the catheter.Performance/functional evaluation: the device was attached to the transducer of the in-house generator.An in-house injection device was used to flush the catheter 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 review: as medical records were not provided, a review could not be performed.Image review: based on the images provided, the posterior tibial artery demonstrated good blood flow can be confirmed.Based on the images provided, the anterior tibial artery blood flow diminished at the level of the talus can be confirmed.Photo review: one electronic photo of the procedure room was reviewed.The photo includes two staff members and the patient lying on a procedural table.The patient is covered in drapes, except for his face.Four monitors showing images are present in the photo.A crosser generator, flowmate injector, and crosser catheter are present.The crosser catheter appears to be connected to the transducer with the crosser generator powered on.An introducer sheath is present and appears to be inserted in the patient.The access site is not visible in the photo, as it is covered by the drapes.A guidewire can be seen inserted through the hub of the introducer sheath.The size of the guidewire could not be determined based on the photo.Based upon the photo provided, the overheating of the crosser catheter could not be confirmed.Conclusion: the investigation is unconfirmed, as the catheter was able to be activated for five minutes during functional testing with no overheating observed.It is unknown if patient (i.E.Length of lesion) and/or procedural issues contributed to this event.It is unknown whether the injector used during the procedure contributed to the catheter reportedly overheating.The definitive root cause could not be determined based upon the available information.Labeling review: the current crosser cto 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.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• 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: 5428723
• MDR Text Key: 38538192
• Report Number: 2020394-2016-00169
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: CRES6
• Device Lot Number: GFYA2927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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: 68 YR
• Patient Weight: 70