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

Catalog Number	CRV135-19P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The caravel microcatheter was returned with the concomitant grand slam guide wire.The separated tip of the caravel was found on the grand slam.Multiple scratches probably made by contacting calcified plaque were observed on the distal shaft where disarrangement of the strands due to accumulated torsion was also found.Scratches attributed to calcified plaque were also on the surface of the remaining tip.Circumferential cracks were generated at the torn end of the tip that indicated tensile stress had contributed to the tip separation.Distal to the torn end of the separated tip, numerous circumferential cracks attributed to tensile stress were found.In the middle of the separated tip, the tip was twisted along with roughened surface and indentation.The distal end of the separated tip was split; the split was extended from a deep scratch.Around the separated tip, the grand slam was bent and stretched distally.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 provided information and investigation outcome, it was presumed that tensile stress had most likely contributed to the observed tip separation on the caravel microcatheter.The tip was likely being caught by the calcified lesion at the time torsion was applied on the caravel.Consequently, the tip would be twisted.Because the tip was twisted, it became stuck on the concomitant grand slam guide wire.Further applied tensile stress generated with removal then exceeded the product design limit and made the stuck tip tear apart.Although there were reportedly no adverse patient effects, observed damage on the tip was too severe to completely rule out a possibility that some fragment(s) might be left in patient.Instructions for use (ifu) states: - [warnings] do not rotate this microcatheter in any situation.(rotating this microcatheter may cause damage to the microcatheter, and may also damage the blood vessel.); - [warnings] if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel.); and, - [malfunction and adverse effects] separation.
Event or Problem Description
It was reported that the pci was performed to treat a severely tortuous, moderately calcified, 90-99% occlusion in the bifurcation of the lcx and om.The tip of an asahi caravel microcatheter broke off in the patient's lcx when trying to withdraw the caravel over an asahi grand slam guide wire.The separated tip remained on the guide wire so that the guide wire was pulled back into a guide extension catheter to successfully retrieve the separated tip.The patient was in stable after the procedure without any adverse effects associated with this event.

• Brand Name: CARAVEL
• 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: 10512704
• Report Number: 3003775027-2020-00138
• Device Sequence Number: 14120757
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)230331(10)200411K10A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152447
• 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): 08/21/2020

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: 03/31/2023
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 200411K10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/10/2020
• 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: Other
• Patient Age: 81 YR