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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION MACH1 CATHETER, PERCUTANEOUS Back to Search Results
Model Number 1260
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Burning Sensation (2146); Heart Failure (2206)
Event Date 04/01/2019
Event Type  Death  
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 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.

 
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Brand NameMACH1
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
FLEXTRONICS INTERNATIONL EUROPE B V
noblestraat 10 14
oostrum lb 5807 GA
NL 5807 GA
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9793935
MDR Text Key182193853
Report Number2134265-2020-02578
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK020028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1260
Device Catalogue Number1260
Device LOT Number0060172522
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/20/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2020 Patient Sequence Number: 1
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