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

Catalog Number	CRV135-19P
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	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).The caravel 135 cm and 150 cm microcatheters were returned for evaluation.The reported caravel 135 cm microcatheter was missing the distal segment of the tip.Microscopic observation of the broken tip end found circumferential cracks on the tip surface that indicated tensile stress had attributed to the observed tip separation.A scratch probably made by contacting calcium was found on the tip surface proximal to the broken tip end.The distal end of the braid tube was observed on the broken tip end; approximately 2 mm of the tip (composed solely of polymer) was considered missing.The returned caravel 150 cm microcatheter that was used in exchange for the subject microcatheter had its tip slightly deformed associated with normal usage.No other damage was found on the caravel 150 cm.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 generated with catheter manipulation or removal had most likely contributed to the reported tip separation.The applied stress would exceed the product design limit when the tip was being caught and its movement was restricted by the calcified lesion.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [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, [malfunctions] separation.
Event or Problem Description
It was reported that the tip of an asahi caravel microcatheter became separated during a pci to treat a mildly calcified 75-90% occlusion in the lcx.The microcatheter was advanced with difficulties through firm plaque of the lesion.Resistance was met during removal and the tip sheared off.The separated tip remained in the lesion.Another caravel microcatheter was used to continue the procedure.A snare was used to successfully retrieve the separated tip.Nothing was left behind.There were no adverse patient effects associated with this event.

• Brand Name: ASAHI 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: 9821722
• Report Number: 3003775027-2020-00049
• Device Sequence Number: 3087004
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)220930(10)191003K04A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 09/30/2022
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 191003K04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/11/2020
• 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: Required Intervention