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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939148201010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 10/16/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling sl otw balloon catheter. The balloon was loosely folded with blood in the wire lumen, contrast in the balloon and inflation lumen. The tip, balloon, markerbands, proximal bond, inner shaft and outer shaft were microscopically and tactile inspected. Inspection found no damage or irregularities. Functional test was carried out by loading an. 018¿ guide wire into the tip of the sterling sl device. The wire advanced through the shaft of the catheter easily and without issue. Inspection of the remainder of the device, found no damage or irregularities. There was no evidence of any damage or irregularities contributing to the reported vasospasm, which could not be confirmed because the clinical circumstances could not be replicated. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
It was reported that a vessel spasm occurred. The target lesion was located in the anterior tibial artery. A non bsc sheath was placed and then a v18 guidewire was positioned. A 2. 0mm x 150mm x 150cm sterling¿ sl balloon catheter was selected for use but could not be loaded onto the wire. Therefore a 2. 0mm x 100mm x 150cm sterling sl balloon was advanced and used to dilate the lesion. Then a vessel spasm occurred which was treated with a spasmolytic nitro medication. The balloon and wire were withdrawn slightly to allow a contrast flush to check the spasm; afterwards the balloon was no longer able to be advanced over the wire so a new balloon was used to complete the case. No further patient complications were reported.
 
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Brand NameSTERLING¿ SL
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key7016191
MDR Text Key91749774
Report Number2134265-2017-10860
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K093720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/11/2019
Device Model NumberH74939148201010
Device Catalogue Number39148-20101
Device Lot Number20874131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2017
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: 11/09/2017 Patient Sequence Number: 1
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