MAUDE Adverse Event Report: ASAHI INTECC SASUKE; MICROCATHETER

Catalog Number	SA145-33N
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Last week i had an issue with the sasuke microcatheter.We had some difficulty taking the catheter out once the side wire was delivered.After coming out, we realized on fluoroscopy that part of the catheter tip was dislodged and remained in the main vessel wire.After we completed the pci, the piece of the catheter had advanced more into distal lad.We then decided to wire a distal branch of the lad and we pushed this piece down.During a pci of the lad -use of sasuke dual lumen catheter.Upon removal of the sasuke noticed distal tip broke off, still in patient, md pushed it further down lad and left it.
Event or Problem Description
Last week i had an issue with the sasuke microcatheter.We had some difficulty taking the catheter out once the side wire was delivered.After coming out, we realized on fluoroscopy that part of the catheter tip was dislodged and remained in the main vessel wire.After we completed the pci, the piece of the catheter had advanced more into distal lad.We then decided to wire a distal branch of the lad and we pushed this piece down.During a pci of the lad -use of sasuke dual lumen catheter.Upon removal of the sasuke noticed distal tip broke off, still in patient, md pushed it further down lad and left it.
Event or Problem Description
Last week i had an issue with the sasuke microcatheter.We had some difficulty taking the catheter out once the side wire was delivered.After coming out, we realized on fluoroscopy that part of the catheter tip was dislodged and remained in the main vessel wire.After we completed the pci, the piece of the catheter had advanced more into distal lad.We then decided to wire a distal branch of the lad and we pushed this piece down.During a pci of the lad -use of sasuke dual lumen catheter.Upon removal of the sasuke -noticed distal tip broke off, still in patient, md pushed it further down lad and left it.

• Brand Name: SASUKE
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 13489022
• Report Number: 3004718255-2022-00250
• Device Sequence Number: 5247572
• Product Code: DQY
• UDI-Device Identifier: 24547327120191
• UDI-Public: (01)24547327120191(17)240430(10)210504F041
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022
• Report Date (Section F): 02/08/2022

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: 04/30/2024
• Device Catalogue Number: SA145-33N
• Device Lot Number: 210504F041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/24/2022
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/04/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 02/08/2022