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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 H7493927012120
Device Problem Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the device was not returned for analysis. The investigation conclusion is design: product enhancement as the device met the designed specification however a modification would improve performance, function or appearance of the product. (b)(4).
 
Event Description
It was reported that the protective sheath was almost left on during the procedure. The target lesion was located in the left anterior descending artery. A 1. 2mm x 12mm threader¿ dilatation catheter was selected for a chronic total occlusion (cto) procedure. The device was advanced in the patient. The plastic piece that comes with the stylet and covers the balloon is tough to see on the catheter; and was noted that it was still on the device. The device was removed and the plastic piece was taken off. The procedure was still completed with this device. No 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 Key7323640
MDR Text Key101980916
Report Number2134265-2018-01473
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 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493927012120
Device Catalogue Number39270-1212
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 Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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