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

Catalog Number	CRU14SA
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Separation (1562)
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 treatment in the sfa, the distal tip of the recanalization catheter was allegedly partially separated from the catheter core wire lumen.It was further reported that the catheter was retracted without incident.Reportedly, another recanalization catheter was used to complete the procedure.There was no reported patient injury.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 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 inspection: the core wire was broken 0.9 cm from the distal tip.The distal tip was examined under microscopic magnification and no material separation was present.The outer catheter was examined under microscopic magnification (40x) and a puncture was observed at the location of the core wire break.No anomalies were noted to the transducer or saline hub, and no kinks were noted to the catheter.Performance/functional evaluation: the patency of the guidewire lumen was tested by advancing an in-house 0.014¿ guidewire.The guidewire was loaded through the rapid exchange junction and exited the distal tip with no issues.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation was confirmed for fracture as the corewire was observed to be broken.The investigation was also confirmed for material puncture as the outer catheter was observed to be punctured at the location of the core wire break.The investigation was unconfirmed for material separation as the distal tip was intact.It is likely that the corewire fracture led to the catheter puncture.However, the definitive root cause for this event could not be determined based upon the available information.It was unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings and precautions: 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 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 or Problem Description
It was reported that during treatment in the sfa, the distal tip of the recanalization catheter was allegedly partially separated from the catheter core wire lumen.It was further reported that the catheter was retracted without incident.Reportedly, another recanalization catheter was 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: 6142910
• Report Number: 2020394-2016-01132
• Device Sequence Number: 1075731
• Product Code: DQY
• UDI-Device Identifier: 10801741125567
• UDI-Public: (01)10801741125567(17)180828(10)GFAV3394
• 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: 08/28/2018
• Device Catalogue Number: CRU14SA
• Device Lot Number: GFAV3394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• 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