MAUDE Adverse Event Report: ASAHI INTECC CARAVEL; MICROCATHETER

Catalog Number CRV150-19P

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Retrograde approach through rca epicardial to lad.Prox xs was advanced with no issues over sion black.Xs wouldn't pass corkscrew spiral in epicardial collateral.Sion black was changed out for suoh03.Wire was able to travel into lad and to distal cap of the prox lad cto.Xs was unable to continue along suoh03.Xs was exchanged for caravel.Caravel was unable to navigate through the corkscrew spiral.Carvel was removed and it appeared to fracture in epicardial.On fluroscopy, it appeared as a radiopaque weld point on the suoh03.Making assumptions that the suoh03 may have kinked or splintered.Finecross m3 was then advanced over suoh03.M3 wouldn't pass corkscrew as well, m3 and suoh03 were removed.There was a slice of something left in the epicardial.A new suoh03 was inserted over the m3 and both wire and microcatheter were advanced to distal segment of the cto, using same epicardial.

• Brand Name: CARAVEL
• Type of Device: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 16004875
• MDR Text Key: 305714891
• Report Number: 3004718255-2022-00284
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 220712K04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2022
• Distributor Facility Aware Date: 12/01/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG