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

Model Number	1260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Burning Sensation (2146); Heart Failure (2206)
Date of Event	04/01/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Date of birth was reported as (b)(6) and age was reported as (b)(6) years.Date of death: reported as (b)(6) 2019.Date of event: event date was estimated from the reported event date of (b)(6) 2019.
Event or Problem Description
It was reported that a patient death occurred.The patient experienced a myocardial infarction (mi) and coronary artery stenting with a drug eluting stent treatment was selected.Contrast media infusion was performed and the guidewire was placed.Balloon catheter angioplasty was performed.A 6f mach1 catheter was used in the procedure.Shortly into the procedure, the patient complained of being unwell and experienced a burning sensation in his head.The patient rapidly deteriorated on the table and suffered heart failure.Patient death occurred.It was suggested by the treating cardiologist that the patient experienced a sudden deterioration related to possible anaphylaxis.
Additional Manufacturer Narrative
A2: date of birth was reported as (b)(6) 2019 and age was reported as 53 years.B2: date of death: reported as (b)(6) 2019 b3: date of event: event date was estimated from the reported event date of (b)(6) 2019.Device eval by manufacturer: the device was not returned for analysis.Records were reviewed.It was confirmed that the mach 1 catheter does not contain or contact polyethylene glycol (peg).
Event or Problem Description
It was reported that a patient death occurred.The patient experienced a myocardial infarction (mi) and coronary artery stenting with a drug eluting stent treatment was selected.Contrast media infusion was performed and the guidewire was placed.Balloon catheter angioplasty was performed.A 6f mach1 catheter was used in the procedure.Shortly into the procedure, the patient complained of being unwell and experienced a burning sensation in his head.The patient rapidly deteriorated on the table and suffered heart failure.Patient death occurred.It was suggested by the treating cardiologist that the patient experienced a sudden deterioration related to possible anaphylaxis.

• Brand Name: MACH1
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9793935
• Report Number: 2134265-2020-02578
• Device Sequence Number: 11406412
• Product Code: DQY
• UDI-Device Identifier: 08714729351306
• UDI-Public: 08714729351306
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 02/20/2022
• Device Model Number: 1260
• Device Catalogue Number: 1260
• Device Lot Number: 0060172522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR