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

Catalog Number	CRU14SA
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
It was reported that during preparation for procedure, the guidewire was allegedly unable to load through the recanalization catheter; rendering the device unusable.Reportedly, another recanalization catheter with a support catheter were used to complete the procedure.There was no reported patient injury.
Additional 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.Visual/microscopic inspection: the sample was returned.The distal tip was examined under microscopic magnification and the outer catheter was noted to be partially separated from the distal tip.A partial circumferential tear was present in the catheter 0.3cm from the distal tip.The marker band was intact.No other anomalies were noted along the length of the catheter.Functional/performance evaluation: the patency of the guidewire lumen was tested with an in-house guidewire.The guidewire was loaded through the hub but was unable to be loaded past the tear in the catheter.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 investigation was confirmed for material separation, as the catheter was partially separated from the distal tip.The investigation was confirmed for torn material, as a partial circumferential tear was observed on the catheter.The investigation was inconclusive for device-device incompatibility, as full functional testing could not be performed due to the material separation.The root cause could not be determined based upon available information.It was unknown whether patient and/or procedural factors 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.- attach the irrigation system to the irrigation lumen on the proximal end of the crosser catheter.- for the crosser catheters 14p, 14s, and 18 only, flush the guidewire lumen of the crosser catheter using a standard 10ml syringe with heparinized saline.Interventional use: - load the crosser catheter 14p, 14s, or 18 over the wire and introduce through rhv.Take care not to damage the tip of the crosser catheter during introduction; no resistance should be encountered during this process.- warning! use extra caution when loading the crosser catheter 18 over a.014¿ or a ¿docking¿ wire, as the significant mismatch in diameters may increase the likelihood of guidewire lumen piercing.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 or Problem Description
It was reported that during treatment in the sfa, the guidewire was allegedly unable to load through the recanalization catheter; therefore, another recanalization catheter and a support catheter were used to complete the procedure.There was no reported patient injury.

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6171919
• Report Number: 2020394-2016-01167
• Device Sequence Number: 19076718
• Product Code: DQY
• UDI-Device Identifier: 10801741125567
• UDI-Public: (01)10801741125567(17)180430(10)GFAP2125
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFAP2125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 80