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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493895915320
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/30/2022
Type of Reportable Event Malfunction
Event or Problem Description
Early 70¿s female with history of coronary artery disease.Procedure: percutaneous intervention, stent placement and balloon angioplasty in the proximal right coronary.Balloon ruptured @ nominal, 2 devices- 2 attempts.3rd one worked well.No known harm to the patient.Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, apex¿ (per site reporter).Will obtain.Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, apex¿ (per site reporter).Will obtain.
 
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Brand Name
APEX¿
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key15461630
Report Number15461630
Device Sequence Number16906865
Product Code LOX
UDI-Device Identifier08714729475644
UDI-Public(01)08714729475644(17)240413(10)27136834
Combination Product (Y/N)N
Initial Reporter StateOH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 08/31/2022
Report Date (Section F) 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberH7493895915320
Device Lot Number27136834
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer09/21/2022
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/21/2022
Usage of Device Unknown
Patient Sequence Number1
Patient SexFemale
Patient Weight94 KG
Date Report Sent to FDA08/31/2022
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