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

Model Number	1260
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that vessel dissection occured.The lesion was located in the right coronary artery.A rotalink advancer, 1.25 mm rotalink burr, 330 cm rotawire and 6f mach1 guiding catheter were selected for use.The rotawire was guided through a non-bsc microcatheter to the distal end of the lesion in the pl branch.It was noted that it was difficult to guide the rotawire through the lesion due to the occlusion, so the wire was spun heavily to get it to the distal point in the pl branch.Subsequently, the burr was advanced in dynaglide mode over the rotawire within the mach1 guide catheter but there was resistance approximately 20cm into the guiding catheter.The rotawire started to spin quite heavily and the distal tip of the wire broke off while the burr was still in the guiding and resulted to a limited local dissection.As the burr was completely stuck while being in the guiding catheter, the burr and wire were retrieved but the wire position was lost.An attempt to rewire the lesion was done using a non-bsc wire which was guided through the microcatheter but the wire became stuck in the dissection.The procedure was discontinued and the dissection was given time to heal; same procedure was to be repeated in a few weeks.After retrieving the burr and rotawire, it looked like the coating was drilled/burred off the rotawire.In addition, material was found wrapped over the rotawire causing the stuck burr.It was unknown if material was from the burr, microcatheter, or guide catheter.The patient had a timi-2 flow (conform pre-procedure) and was stable.
Event or Problem Description
It was reported that vessel dissection occured.The lesion was located in the right coronary artery.A rotalink advancer, 1.25 mm rotalink burr, 330 cm rotawire and 6f mach1 guiding catheter were selected for use.The rotawire was guided through a non-bsc microcatheter to the distal end of the lesion in the pl branch.It was noted that it was difficult to guide the rotawire through the lesion due to the occlusion, so the wire was spun heavily to get it to the distal point in the pl branch.Subsequently, the burr was advanced in dynaglide mode over the rotawire within the mach1 guide catheter but there was resistance approximately 20cm into the guiding catheter.The rotawire started to spin quite heavily and the distal tip of the wire broke off while the burr was still in the guiding and resulted to a limited local dissection.As the burr was completely stuck while being in the guiding catheter, the burr and wire were retireved but the wire position was lost.An attempt to rewire the lesion was done using a non-bsc wire which was guided through the microcatheter but the wire became stuck in the dissection.The procedure was discontinued and the dissection was given time to heal; same procedure was to be repeated in a few weeks.After retrieving the burr and rotawire, it looked like the coating was drilled/burred off the rotawire.In addition, material was found wrapped over the rotawire causing the stuck burr.It was unknown if material was from the burr, microcatheter, or guide catheter.The patient had a timi-2 flow (conform pre-procedure) and was stable.It was further reported that the burr together with the wire were removed manually as the burr was stuck on the wire.
Additional Manufacturer Narrative
Age or date of birth : age at time of event - 18 years or older.Mfr site : mfr site address 2: no.20905 int.A.Col.,cd.Industrial, 22444.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8460916
• Report Number: 2134265-2019-03124
• Device Sequence Number: 19597361
• Product Code: DQY
• UDI-Device Identifier: 08714729351986
• UDI-Public: 08714729351986
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/01/2019

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: 10/29/2021
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060156703
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other