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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 Puncture/Hole (1504); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2022
Event Type  malfunction  
Event Description
It was reported that shaft perforation occurred.A 7.0mmx30mmx80cm (4f) sterling balloon catheter was prepared for use.However, prior to advancing over the guidewire, the physician noticed that the shaft of the balloon was torn.Additionally, it was noted that the device was kinked.The procedure was completed with a 7x20 sterling balloon catheter.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.A kink was visible 55.8 cm from the hub.The balloon was inflated to 14atm and held for one minute.There was no further damage to the sterling balloon.
 
Event Description
It was reported that shaft perforation occurred.A 7.0mmx30mmx80cm (4f) sterling balloon catheter was prepared for use.However, prior to advancing over the guidewire, the physician noticed that the shaft of the balloon was torn.Additionally, it was noted that the device was kinked.The procedure was completed with a 7x20 sterling balloon catheter.No patient complications were reported.
 
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Brand Name
STERLING
Type of Device
CATHETER, 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14885532
MDR Text Key303423687
Report Number2134265-2022-06945
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729757436
UDI-Public08714729757436
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2023
Device Model Number24690
Device Catalogue Number24690
Device Lot Number0025181569
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
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 Sequence Number1
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