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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 H74939031601610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Embolism (1829)
Event Date 07/03/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that no embolism occurred after standard percutaneous transluminal angioplasty (pta). It was confirmed that the dissection noted post standard pta treatment and after post-dilatation were the same and the complication was not resolved.
 
Manufacturer Narrative
Describe event or problem, and patient codes updated. Bsc id: (b)(4). Tw#: (b)(4).
 
Event Description
It was further reported that during the index procedure, an embolism was also noted which was then treated with thrombus aspiration.
 
Manufacturer Narrative
Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
(b)(6) clinical study. It was reported that vessel dissection occurred. In (b)(6) 2017, index procedure was performed. The target lesion was located in the left superficial femoral artery which had 100% stenosis, reference vessel diameter of 6. 5mm, a length of 95mm, and was classified as a tasc ii b lesion. The target lesion was treated with pre-dilatation using 5mmx100mm balloon catheter and standard percutaneous transluminal angioplasty (pta) was performed with 6. 0mmx150mmx150cm (4f) sterling¿ balloon catheter. Following this intervention, grade b dissection was noted. Post dilatation was also performed and complication was resolved.
 
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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 Key6732030
MDR Text Key108508748
Report Number2134265-2017-07367
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,Followup
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Model NumberH74939031601610
Device Catalogue Number39031-60161
Device Lot Number19232883
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 Received08/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
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: 07/21/2017 Patient Sequence Number: 1
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