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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 24703
Device Problems Contamination (1120); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 03/17/2020
Event Type  malfunction  
Event Description
It was reported that the device became unsterile.A 3.0mm x 150mm x 150cm sterling sl balloon catheter became unsterile upon opening the package.It was observed that the balloon was not fully seated in the plastic holder and flew out of the package.It became contaminated immediately striking the circulator in the arm.The device was not used in the procedure.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.Device was in carrier tubing.There were no defects or damage to the carrier tubing or to the hub or strain relief of the device.The balloon protector was still in place.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported defective or damaged packaging.
 
Event Description
It was reported that the device became unsterile.A 3.0mm x 150mm x 150cm sterling sl balloon catheter became unsterile upon opening the package.It was observed that the balloon was not fully seated in the plastic holder and flew out of the package.It became contaminated immediately striking the circulator in the arm.The device was not used in the procedure.
 
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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 Key9868598
MDR Text Key184623394
Report Number2134265-2020-03723
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729782315
UDI-Public08714729782315
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,health
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/13/2021
Device Model Number24703
Device Catalogue Number24703
Device Lot Number0024932820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2020
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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