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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE THREADER¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE THREADER¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926912120
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
Age at time of event: over 18 years old. (b)(4). Bsc id: (b)(4). Tw: (b)(4).
 
Event Description
It was reported that tip detachment occurred. The target lesion was located in the circumflex artery. A 1. 2mm x 12mm threader¿ balloon catheter was advanced for treatment. However, the distal tip of the device broke off. The detached fragment was lodged and then stented in the first obtuse marginal (om1) artery. No attempts were made to retrieve the detached fragment as the risk of retrieval was greater than stenting in the om1. The procedure was completed with a different device. No further patient complications were reported and the patient's status was fine.
 
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Brand NameTHREADER¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7633618
MDR Text Key112161557
Report Number2134265-2018-05624
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K134031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2020
Device Model NumberH7493926912120
Device Catalogue Number39269-1212
Device Lot Number21798849
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/25/2018 Patient Sequence Number: 1
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