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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 24690
Device Problems Material Rupture (1546); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Event Description
It was reported that balloon pinhole occurred. The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. Pre-inflation was performed with a 3mm balloon. After the non-boston scientific guidewire was crossed to the lesion, a 5. 0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation. However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted. The device was removed. In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon. The procedure was completed with a different device. There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that balloon pinhole occurred. The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. Pre-inflation was performed with a 3mm balloon. After the non-boston scientific guidewire was crossed to the lesion, a 5. 0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation. However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted. The device was removed. In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon. The procedure was completed with a different device. There were no patient complications nor injuries 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 Key13599266
MDR Text Key286138041
Report Number2134265-2022-02030
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24690
Device Catalogue Number24690
Device Lot Number0028176826
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2021
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: 02/25/2022 Patient Sequence Number: 1
Treatment
GUIDEWIRE USED: CRUISE; INTRODUCER SHEATH USED: DESTINATION 6F
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