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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ CATHETER, PERCUTANEOUS Back to Search Results
Model Number H74939031602210
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Occlusion (1984)
Event Date 06/20/2017
Event Type  Injury  
Manufacturer Narrative
It is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
(b)(4) clinical study. It was reported that dissection and restenosis occurred. In (b)(6) 2017, clinical status assessment identified the patient¿s qualifying condition as rutherford category 2. The index procedure was performed on the same day. The target lesion was located in the left superficial femoral artery had 99% stenosis, reference vessel diameter of 4. 76 mm, a length of 180 mm, and was classified as a tasc ii c lesion. The lesion was treated with pre-dilatation using 5 mmx100mm balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with a 6. 0mmx220mmx150cm (4f) sterling¿ balloon catheter to treat the target lesion. Post deployment of sterling¿ pta balloon, dissection b was noted and no action was taken for the same. Two days post procedure, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, the patient was noted to have left superficial femoral stenosis. No action was taken to treat the event. The event was considered to be not recovered/ not resolved.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that on (b)(6) 2017, the patient presented with symptoms of r-3 intermittent claudication. Vascular ultrasound revealed mid mild to moderate stenosis in the left sfa proximal and slightly accelerated blood flow was noted at the proximal. In (b)(6) 2018, patient was hospitalized for further evaluation and management. The 99% stenosis in left sfa was treated with prestenotic dilatation using a non-bsc, 5 mm x 150 mm balloon followed by long inflation with 6 mm x 150 mm and 6 mm x 120 mm. Non-bsc balloons. Post treatment, 15% stenosis was noted. The following day, the event was considered to be recovered and resolved. The patient was discharged on the same day.
 
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Brand NameSTERLING¿
Type of DeviceCATHETER, 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 Key7289957
MDR Text Key100715989
Report Number2134265-2018-01132
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Model NumberH74939031602210
Device Catalogue Number39031-60221
Device Lot Number20481357
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 Received04/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2017
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: 02/22/2018 Patient Sequence Number: 1
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