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

Model Number	1770
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6): mfr site address: (b)(4).
Event or Problem Description
It was reported that decrease in blood pressure and bradycardia occurred.The 99% stenosed, 15mm in length, 3.5mm in diameter target lesion was located in a mildly tortuous and severely calcified lesion was located in the proximal right coronary artery.A mach 1 guide catheter was selected for use.During percutaneous coronary intervention (pci), ablation was performed using 1.75mm rotalink plus burr over a rotawire.Ablation was performed three times at 205,000 rpm for a duration of 10 seconds without staying in one place.However, when the 1.75mm burr was removed into the guide catheter the blood pressure decreased and bradycardia occurred.The symptoms were improved by drug administration.According to the physician, the cause of the blood pressure decrease and bradycardia might be the ablated debris that flowed to the periphery.There was some damage observed within the inner lumen of the guide catheter, but the physician did not think this contributed to the patient complications.The procedure was completed with the same device.The patient's current condition is good.
Additional Manufacturer Narrative
(b)(6).(b)(4).
Event or Problem Description
It was reported that decrease in blood pressure and bradycardia occurred.The 99% stenosed, 15mm in length, 3.5mm in diameter target lesion was located in a mildly tortuous and severely calcified lesion was located in the proximal right coronary artery.A mach 1 guide catheter was selected for use.During percutaneous coronary intervention (pci), ablation was performed using 1.75mm rotalink plus burr over a rotawire.Ablation was performed three times at 205,000 rpm for a duration of 10 seconds without staying in one place.However, when the 1.75mm burr was removed into the guide catheter the blood pressure decreased and bradycardia occurred.The symptoms were improved by drug administration.According to the physician, the cause of the blood pressure decrease and bradycardia might be the ablated debris that flowed to the periphery.There was some damage observed within the inner lumen of the guide catheter, but the physician did not think this contributed to the patient complications.The procedure was completed with the same device.The patient's current condition is good.Device evaluated by mfr.The device was returned for analysis.The outside of the shaft and tip were microscopically and visually examined.There was a kink 1cm proximal of the tip.The tip was microscopically examined and it was revealed that there was ptfe pulled back and some braiding exposed at the very tip.The x-ray presented no damage to the inside of the shaft.The damage to the tip is consistent to damage caused by interaction with another device during use.The 1.75mm rotablator burr catheter used in the procedure was not returned for analysis, so functional testing was completed with a test 2.15mm rotablator burr catheter.A 2.15mm burr catheter was selected as the 8f mach1 is compatible with a burr up to 2.25mm and a 1.75mm burr catheter was not available for testing.The burr catheter was able to be inserted and advanced through the mach1 with no resistance until that burr got to the kink.The burr was able to pass the kink but there was a slight resistance at only the kinked shaft not at the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm any damage to the inside of the shaft but did confirm damage to the inside of the tip and a kink at the end of the shaft.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7840514
• Report Number: 2134265-2018-60472
• Device Sequence Number: 19223764
• Product Code: DQY
• UDI-Device Identifier: 08714729382775
• UDI-Public: 08714729382775
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 11/08/2020
• Device Model Number: 1770
• Device Catalogue Number: 1770
• Device Lot Number: 0060097048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/03/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 63