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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24702
Device Problems Contamination (1120); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
It was reported that the device was contaminated.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was selected for use.However, the balloon was damaged and the reel appeared dirty.The procedure was completed with different device.No patient complications were reported.
 
Event Description
It was reported that the device was contaminated.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was selected for use.However, the balloon was damaged and the reel appeared dirty.The procedure was completed with different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual inspection revealed that the guidewire lumen within the balloon was curved with a "wavy" appearance and the balloon is deformed.There is blood present on the carrying tube.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
 
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Brand Name
STERLING SL
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12144693
MDR Text Key261024573
Report Number2134265-2021-08530
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729782476
UDI-Public08714729782476
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
Type of Report Initial,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2023
Device Model Number24702
Device Catalogue Number24702
Device Lot Number0026958087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2021
Date Manufacturer Received08/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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