MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. SILVERWAY; ANGIOGRAPHIC GUIDE WIRE

Catalog Number	SA0035N26S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Registration number:(b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event.No modification was made to coating process or coating material.No other similar product experience report was received from this lot.As lot history records review found no anomaly including coating process that would largely affect lubricity or tactile feedback of a guide wire, it was presumed that anatomical conditions or wire manipulation technique might have contributed to the reported pseudoaneurysm development.It was concluded that this event was not attributed to product quality.No capa will be taken.The malfunction and adverse effects section of the instructions for use (ifu) states dissection of blood vessels and perforation of blood vessels.
Event or Problem Description
It was reported that an asahi silverway diagnostic guide wire was used to gain access to the rca/lad.While advancing the guide wire via the left radial artery, it unintentionally entered into the thyrocervical branch or dissection plane and developed a pseudoaneurysm (psa).Coil embolization was performed to treat the psa.The patient was fine; however, this resulted in a week delay of a coronary artery bypass grafting (cabg).
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Registration number:(b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event.No modification was made to coating process or coating material.No other similar product experience report was received from this lot.As lot history records review found no anomaly including coating process that would largely affect lubricity or tactile feedback of a guide wire, it was presumed that anatomical conditions or wire manipulation technique might have contributed to the reported pseudoaneurysm development.It was concluded that this event was not attributed to product quality.No capa will be taken.The malfunction and adverse effects section of the instructions for use (ifu) states dissection of blood vessels and perforation of blood vessels.
Event or Problem Description
It was reported that an asahi silverway diagnostic guide wire was used to gain access to the rca/lad.While advancing the guide wire via the left radial artery, it unintentionally entered into the thyrocervical branch or dissection plane and developed a pseudoaneurysm (psa).Coil embolization was performed to treat the psa.The patient was fine; however, this resulted in a week delay of a coronary artery bypass grafting (cabg).

• Brand Name: SILVERWAY
• Common Device Name: ANGIOGRAPHIC GUIDE WIRE
• 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: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 12880083
• Report Number: 3003775027-2021-00191
• Device Sequence Number: 20079156
• Product Code: DQX
• UDI-Device Identifier: 04547327121620
• UDI-Public: (01)04547327121620(17)240430(10)210507T23A
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: SA0035N26S
• Device Lot Number: 210507T23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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: Required Intervention
• Patient Sex: Unknown