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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24716
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/30/2020
Event Type  Injury  
Event Description
It was reported that balloon rupture and balloon detachment occurred. The target lesion was located in the heavily calcified left superficial femoral artery. A 6. 0x220x150 sterling balloon catheter was advanced for dilatation. However, during the second inflation, the balloon ruptured circumferential and a piece of the balloon remained in the patient. The procedure took an extra three hours of trying to remove the piece of the balloon by snare and also a non-bsc filter wire that sheared off in the heavily calcified lesion. The fragmented piece had to be left in the patient and a covered stent was deployed to jail it up against the wall. The filter wire also tried to be retrieved and was unsuccessful, so it was jailed up against the wall along with the balloon fragment. There were no further complications reported.
 
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Brand NameSTERLING
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9943481
MDR Text Key187060834
Report Number2134265-2020-04724
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/08/2021
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0025187239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2020
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: 04/09/2020 Patient Sequence Number: 1
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