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

Catalog Number	CRUS6106
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2017
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 a heavy calcified occlusion procedure beginning in the sfa and extending to the popliteal tibial artery, after approximately three minutes of activation, the recanalization catheter allegedly broke approximately 4cm from the distal tip and detached.It was further reported that during retraction the broken segment secured between the recanalization catheter and the support catheter and was removed without incident.Another recanalization catheter was reportedly used and the procedure was completed.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.This is the only complaint reported to date for this lot number and failure mode.Visual/microscopic inspection: the crosser sample appeared to be clean.The distal end was examined under magnification (50x) and it was observed that the distal tip was missing from the catheter and was not returned.The core wire remained within the catheter and was measured to be 100.3cm, indicating that 5.7cm of the core wire and distal tip were not returned for evaluation.Outer lumen measured at approximately 100.1cm from strain relief.No anomalies noted for saline hub or transducer handle.No kinks noted.No further testing viable due to sample condition.(i.E detached tip).Functional/performance evaluation: functional/performance evaluation could not be performed due to sample condition.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 device was returned.The investigation was confirmed for tip detachment as the device was returned with 5.7cm of the distal tip missing.Per the reported details, the tracking path to the target anatomy was heavily calcified.Therefore, it is possible that patient factors contributed to the reported event.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings and precautions: when using the crosser® catheter 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.Do not exceed 5 minutes of activation time as crosser catheter malfunction may occur.If 5 minutes of activation time is achieved exchange for a second crosser catheter before resetting the crosser generator.Adverse events: as with most percutaneous interventions, potential adverse effects include: bleeding which may require transfusion or surgical intervention, hematoma, perforation, dissection, guidewire entrapment and/or fracture, hypertension/hypotension, infection or fever, allergic reaction, pseudoaneurysm or fistula aneurysm, acute reclosure, thrombosis, ischemic events, distal embolization, excessive contrast load resulting in renal insufficiency or failure, excessive exposure to radiation, stroke/cva, restenosis, repeat catheterization / angioplasty, peripheral artery bypass, amputation, death or other bleeding complications at access site.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.Set the irrigation system to 0.3ml/sec (18ml/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.Interventional use: advance the guidewire and crosser catheter to the lesion site.Withdraw the guidewire approximately 1cm within the catheter so that the tip of the crosser catheter is the leading edge.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 s6 catheter.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 a heavy calcified occlusion procedure beginning in the sfa and extending to the popliteal tibial artery, after approximately three minutes of activation, the recanalization catheter allegedly broke approximately 4cm from the distal tip and detached.It was further reported that during retraction the broken segment secured between the recanalization catheter and the support catheter and was removed without incident.Another recanalization catheter was reportedly used and the procedure was completed.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: 6483732
• Report Number: 2020394-2017-00329
• Device Sequence Number: 1198601
• Product Code: MCW
• UDI-Device Identifier: 10801741125642
• UDI-Public: (01)10801741125642(17)180828(10)GFAV3380
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112308
• 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): 05/23/2017

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: CRUS6106
• Device Lot Number: GFAV3380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 62