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	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4), registration number: (b)(4).The crosswalk peripheral support catheter was returned for evaluation.Fragmentation of the tip was confirmed on the returned catheter.A crushed shaft due to bending was observed at the distal marker band.Microscopic observation of the tip found that the tip polymer was completely detached at the junction of the tip polymer and the shaft tube to expose the underlying braid tube.The exposed braid tube was stretched.A longitudinal crack was observed at the broken edge of the tip.These findings indicated that tensile stress had contributed to shearing off the tip from the shaft while the tip had likely been restricted its movement.The mid part of the tip was partially missing and the inner jacket was exposed.The exposed inner jacket was buckled.All cracks including the ones that lead to chipping the tip polymer originated from the circumferential direction and propagated longitudinally, implying fragmentation of the mid part of the tip was most due to repeated bending stress.A longitudinal scratch was also found on the tip surface that indicated the tip was in contact likely with calcium.As seen in the mid part of the tip, circumferentially originated cracks that propagated in the longitudinal direction were observed in the distal part of the tip; therefore, fragmentation in the distal part was most likely attributed to repeated bending stress.A longitudinal groove observed on the surface of the distal tip indicated that the tip was bit likely by calcium.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 investigation outcome, it was presumed that repeated bending stress generated with catheter manipulation had most likely contributed to the observed tip fragmentation of the returned crosswalk support catheter.The applied stress would localize and therefore exceed the product design limit when tip movement was restricted likely by calcium.Tensile stress generated likely during removal made the tip to detach from the shaft.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 a crosswalk peripheral support catheter fell off during a percutaneous peripheral intervention to treat mildly tortuous, mildly calcified, random lesions in the superficial femoral artery, tibial artery, and popliteal artery.The physician determined to leave the separated tip in situ.The procedure itself had completed without delay.There was no impact on patient outcome associated with this event.

• 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: 12368752
• Report Number: 3003775027-2021-00147
• Device Sequence Number: 11074008
• Product Code: DQY
• UDI-Device Identifier: 04547327133494
• UDI-Public: (01)04547327133494(17)240331(10)210406K02A
• 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): 08/25/2021

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: 03/31/2024
• Device Catalogue Number: PSC18090A
• Device Lot Number: 210406K02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: 58 YR
• Patient Weight: 220