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

Model Number	24970
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a distal tip break occurred.The 100% stenosed, target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A mach 1 guide catheter and a non-bsc dilation catheter were selected for use.The distal tip broke as both devices were being advanced to the lesion that was described to be hard.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.
Event or Problem Description
It was reported that a distal tip break occurred.The 100% stenosed, target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A mach 1 guide catheter and a non-bsc dilation catheter were selected for use.The distal tip broke as both devices were being advanced to the lesion that was described to be hard.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.It was further reported that the distal tip break was described as a crushed distal tip and not separated.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).H6 device code corrected from detachment of device or device component a0501 to material integrity problem a04.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15279239
• Report Number: 2134265-2022-08603
• Device Sequence Number: 6927852
• Product Code: DQY
• UDI-Device Identifier: 08714729403531
• UDI-Public: 08714729403531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2025
• Device Model Number: 24970
• Device Catalogue Number: 24970
• Device Lot Number: 0060374220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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 Sex: Unknown