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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 H74939148308010
Device Problem Torn Material (3024)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the 3. 0 mm x 80 mm x 150 cm sterling¿ sl balloon was advanced to the superficial femoral artery and inflated twice. The distal portion of the balloon tore off while inside the patient. There was an attempt to remove the detached portion however it could not be recovered. The fragment was then pressed against the vessel wall with a stent where it remains inside the patient. The patient was reported to be doing fine.
 
Manufacturer Narrative
Device evaluated by mfr. The returned product consisted of a sterling sl balloon catheter, the distal portion of the balloon was not returned. Device analysis determined the condition of the returned device was consistent with the complaint incident. The balloon has a longitudinal tear starting 2mm from the proximal markerband sand continues to the distal end of the torn balloon. The balloon is completely circumferentially torn off 30mm from the proximal balloon weld and the distal portion of the balloon was not returned. There are numerous shaft kinks. The inner shaft is stretched. The tip is damaged. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported that the 3. 0mm x 80mm x 150cm sterling sl balloon was advanced to the superficial femoral artery and inflated twice. The distal portion of the balloon tore off while inside the patient. There was an attempt to remove the detached portion however it could not be recovered. The fragment was then pressed against the vessel wall with a stent where it remains inside the patient. The patient was reported to be doing fine.
 
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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 Key7441481
MDR Text Key105853608
Report Number2134265-2018-03175
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,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberH74939148308010
Device Catalogue Number39148-30801
Device Lot Number21454182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2017
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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