MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CROSSWALK; PERCUTANEOUS CATHETER

Catalog Number	PSC18090A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information, it was presumed that stress generated by continuous catheter manipulation against resistance had likely damaged the tip of the reported crosswalk support catheter.The applied stress would localize and therefore exceed the product design limit when the tip movement was being restricted by cto or small collateral.Upon removal, the damaged tip in trapping collateral was likely detached from the rest.It was concluded that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [warnings] carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out the cause of the resistance in order to avoid damage to blood vessels and separation or kinking of the product.[malfunctions and adverse effects] separation.
Event or Problem Description
It was reported that the tip of an asahi crosswalk peripheral support catheter had broken off in a collateral branch of the tibial artery during a peripheral intervention to treat a moderately calcified, moderately tortuous, chronic total occlusion (cto) in the mid tibial artery.While attempting to bring the crosswalk up from the pedal sheath over a non-asahi v-18 guide wire, force was applied against resistance.The tip of the crosswalk got directed into a small branch and got stuck and was left in the small vessel off the left tibial.The physician did not attempt to recover the tip as it went into a collateral.The doctor switched to a non-asahi cxi support catheter and there was no significant delay to the case.The patient outcome was normal.The procedure was finished and all was well.

• Brand Name: CROSSWALK
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12375536
• Report Number: 3003775027-2021-00150
• Device Sequence Number: 14554700
• Product Code: DQY
• UDI-Device Identifier: 04547327133494
• UDI-Public: (01)04547327133494(17)240430(10)210521K46A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: PSC18090A
• Device Lot Number: 210521K46A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 65 YR
• Patient Weight: 115