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

Model Number	CRV150-19P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(6), registration number: (b)(4).The reported caravel microcatheter was returned for investigation.The returned caravel microcatheter was missing its tip.The torn braids were coming out of the breakage end of the catheter.Proximal to the breakage end, helical scratches were observed.The catheter lumen was narrowed down due to the braid tube and the inner polymer jacket that were gathered inwards by accumulated torsion.These findings indicated that approximately 5mm of the tip was torn off and missing.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 and investigation outcome, it was presumed that torsion was applied on the subject caravel while its tip was being trapped in the occluded lesion.The stress likely was accumulated between the tip and the shaft segments, tearing off the tip when the accumulated stress exceeded the product design limit.It was concluded that this event was not attributed to product quality.Capa: no capa will be taken.The 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.) [malfunctions and adverse effects].- separation.
Event or Problem Description
It was reported that an asahi caravel microcatheter was used to cross a moderately calcified lesion at the mid left circumflex coronary artery (lcx) during a percutaneous coronary intervention (pci).When the caravel microcatheter got caught in the lesion and withdrawal manipulation was applied, the catheter tip was detached and left in the patient anatomy.Although an attempt with snare was made to retrieve, the tip fragment was embedded in the calcium and could not be removed.The physician decided to treat the patient conservatively and stopped the procedure.It was informed that there was no impact on the patient, who was discharged after the procedure and was doing fine with no health hazard.
Additional Manufacturer Narrative
As we received an email time-stamped wednesday, on (b)(6) 2024 5:54 am at our end from (b)(6) , mdr data systems team, to inform us of the discrepancies between the device identification fields of the electronic equivalent of the fda form 3500a that we had submitted compared to the information included for the corresponding fields in the gudid.After comparing the information in the previous submitted mdr with that in the corresponding fields in the gudid, we determined to submit this supplemental report.The changes we intend to make are as follows: d3: manufacturer name, city, and state - from asahi intecc co., ltd.To asahi intecc co., ltd.D4: model # - from no entry to crv150-19p d5: catalog # - from crv150-19p to no entry g1: contact office - from asahi intecc co., ltd.To asahi intecc co., ltd.H4: device manufacture date - from 28-7-2022 to no entry.

• 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
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 18036953
• Report Number: 3003775027-2023-00110
• Device Sequence Number: 17956839
• Product Code: DQY
• UDI-Device Identifier: 04547327108782
• UDI-Public: (01)04547327108782(17)250630(10)220712K04A
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 06/30/2025
• Device Model Number: CRV150-19P
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 220712K04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic