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

Catalog Number CRE14S

Device Problems Material Separation (1562); Device Inoperable (1663); Torn Material (3024); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records or 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 device has been returned to the manufacturer for evaluation.The investigation of the reported event 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 a product demonstration, the recanalization catheter allegedly stop vibrating after approximately one minute of activation.It was further reported that the noise of the catheter allegedly became frail and unusual.There was no reported patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the sample was returned.The core wire was intact.The distal tip was examined under microscopic magnification and material separation was observed.The outer catheter was examined under microscopic magnification and a partial circumferential tear was observed.No anomalies were noted to the transducer or saline hub, and no kinks were noted to the catheter.Functional/performance evaluation: the patency of the guidewire lumen was tested with an in-house guidewire and was unable to advance through the distal tip due to the partial circumferential tear.The device was attached without issue to the transducer of the in-house generator.Once connected to the in-house generator, an in-house device was used to flush the device with saline.The device was able to produce vibrations throughout the entire length of the catheter, and no unusual noises were heard.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.No unusual noises were emitted from the catheter during functional testing.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was returned.The investigation is unconfirmed for device inoperable as the device was able to activate and pass tile testing.The investigation is confirmed for material separation as the distal tip was separating from the outer catheter.The investigation is also confirmed for a tear as a partial circumferential tear was observed on the outer catheter.The definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.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.Set up: - back the rigid portion of the catheter out of the end of the hoop, then carefully unsnap the catheter from the hoop with a gentle twisting motion 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 14p, 14s, or 18 catheter.(b)(4).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 a product demonstration, the recanalization catheter allegedly stopped vibrating after approximately one minute of activation.There was no patient involvement.

• Brand Name: CROSSER 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: 5972010
• MDR Text Key: 55425202
• Report Number: 2020394-2016-00896
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CRE14S
• Device Lot Number: GFAP2122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• 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