MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MACH1; CATHETER, PERCUTANEOUS

Model Number	1260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that dissection occurred, requiring additional intervention.The patient was undergoing percutaneous coronary intervention.Vascular access was obtained via the right radial artery.The 85% stenosed, 4.0-4.5mmx53mm, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the severely tortuous and moderately calcified middle right coronary artery (rca).An opticross imaging catheter was used to study the morphology of the lesion.After a mach1 jr 4 6f guide-catheter was engaged coaxially and a samurai guidewire crossed the lesion, pre-dilation was performed with a 3.50mm x 15mm emerge balloon catheter.With the help of 6f guidezilla long catheter-guide extension, a 4.0mm x 20mm synergy xd drug-eluting stent (des) was deployed.A 4.0mm x 12mm nc emerge balloon catheter was then used for post dilation.Using the same opticross device, the physician noted that a type e dissection had occurred from the proximal to the ostial part of the rca.The dissection was considered to have been caused by the guidezilla and mach1 catheters.When they were used resistance was felt, and the devices were engaged deeply into the rca causing the dissection.The guiding catheters and the guidewire were removed, and a 4.0mm x 38mm synergy xd was then utilized to cover the dissected area of the lesion.The procedure completed with different devices and the patient was stable post-procedure.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20021026
• Report Number: 2124215-2024-50920
• Device Sequence Number: 7448942
• Product Code: DQY
• UDI-Device Identifier: 08714729351955
• UDI-Public: 08714729351955
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K020028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060468959
• 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: 08/02/2024
• Initial Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 06/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - SAMURAI AND MARVEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male