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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 H74939147301010
Device Problems Balloon; Difficult to Remove; Torn Material; Catheter
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that catheter removal difficulties were encountered and balloon tear occurred. A 3. 0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation. However during withdrawal, a tear was noted on the balloon and the device was sectioned on the holder. The guide and the balloon were removed from the patient. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter with an unidentified guide wire still inserted. The balloon was loosely folded. There was contrast in the inflation lumen. Device analysis determined the condition of the returned device was consistent with the complaint incident. The outer shaft, inner shaft, balloon and tip were microscopically examined. There were numerous hypotube kinks. There was tip damage. The wire lumen inside the balloon was buckled. The shaft was completely separated 134. 5cm from the hub. The fracture faces were stretched prior to separation. Functional testing for balloon leak through inflation could not be conducted due to the shaft separation. Visual inspection of the balloon did not reveal any damages. The inner and outer lumen was torn at the exit notch and could contribute to the balloon leak. The guide wire was successfully removed from the distal portion of the detached catheter. The guide wire was separated 27cm from the tip. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).

 
Event Description

It was reported that catheter removal difficulties were encountered and balloon tear occurred. A 3. 0mm x 100mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation. However during withdrawal, a tear was noted on the balloon and the device was sectioned on the holder. The guide and the balloon were removed from the patient. No 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 Key6393516
Report Number2134265-2017-01699
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device MODEL NumberH74939147301010
Device Catalogue Number39147-30101
Device LOT Number19031834
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2016
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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