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

Model Number	1260
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified left main artery.A mach1 guiding catheter was selected for use in a percutaneous coronary intervention procedure.A stent was placed followed by ballooning.The balloon expanded after slightly entering into the guiding catheter.It was noted that the tip of the guiding catheter got separated, and it flowed into the direction of the left circumflex artery.Fluoroscopy was performed and it was confirmed that the tip detached.The physician tried to retrieve the tip with a balloon catheter, but it could not be retrieved.It was successfully removed with goose neck snare.The procedure was completed with another of same device.No complications were reported.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.Analysis of the tip, shaft, hub/strain relief included microscopic and visual inspection.Inspection revealed numerous kinks in the shaft and tip separation with the distal most portion (approximately 2mm) missing from the device.Analysis of the rest of the device found no other damage or irregularities.
Event or Problem Description
It was reported that tip detachment occurred.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified left main artery.A mach1 guiding catheter was selected for use in a percutaneous coronary intervention procedure.A stent was placed followed by ballooning.The balloon expanded after slightly entering into the guiding catheter.It was noted that the tip of the guiding catheter got separated, and it flowed into the direction of the left circumflex artery.Fluoroscopy was performed and it was confirmed that the tip detached.The physician tried to retrieve the tip with a balloon catheter, but it could not be retrieved.It was successfully removed with goose neck snare.The procedure was completed with another of same device.No complications were reported.It was further reported that the balloon catheter used in the procedure was a non-bsc balloon catheter and the patient's current condition is good.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8869893
• Report Number: 2134265-2019-09303
• Device Sequence Number: 13937446
• Product Code: DQY
• UDI-Device Identifier: 08714729350781
• UDI-Public: 08714729350781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 10/01/2021
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060151622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention