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

Model Number	1260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that device break occurred.The target lesion was located in the left anterior descending artery.A mach1 guide catheter was selected for use in a percutaneous coronary intervention procedure.However, during unpacking, device was already broken and buckled.The device did not enter the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).The mach1 guide catheter was returned for analysis.The device was visually and microscopically examined.Inspection of the hub, strain relief, shaft and tip revealed a kink in the shaft 1.5cm proximal of the tip.Inspection of the remainder of the device found no other damage or defect.Product analysis could not confirm the reported event as there was no break in the shaft.
Event or Problem Description
It was reported that device break occurred.The target lesion was located in the left anterior descending artery.A mach1 guide catheter was selected for use in a percutaneous coronary intervention procedure.However, during unpacking, device was already broken and buckled.The device did not enter the patient's body.No patient complications were reported.

• 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: 17119402
• Report Number: 2124215-2023-30074
• Device Sequence Number: 20476477
• Product Code: DQY
• UDI-Device Identifier: 08714729350644
• UDI-Public: 08714729350644
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060414989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 78 KG