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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 24715
Device Problems Entrapment of Device (1212); Failure to Advance (2524); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that catheter entrapment on guidewire occurred.Vascular access was obtained via crossover approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After the lesion was crossed with a thruway guidewire and pre-dilated with a 4mm balloon, a 6mm x 120mm and 7mm x 120mm eluvia stents were implanted.A 6.0x150x150 sterling balloon catheter was advanced for post-dilation but severe resistance was encountered when the balloon started to come out from the tip of the 6fr non-bsc sheath and it could not be delivered smoothly into the stent.Delivery was performed while resistance was felt, and inflation of the balloon was performed about 3 times.However, during removal, the balloon was stuck with the guide wire and it could not be removed.Subsequently, the device was removed as a set with the guidewire and the procedure was completed.No patient complications nor injuries were reported.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluation by mfr.: the returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The inner shaft was separated from the manifold.The outer shaft was buckled at 111.2cm for 13mm and at 115.4cm for 1mm.The outer shaft was stretched down starting at 120.8cm for approximately 10cm.The inner shaft was buckled 131.5cm from the strain relief for 10.6cm extending distally and 6mm proximal of the tip for 23mm extending proximally.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a guidewire in the device that could not be removed.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that catheter entrapment on guidewire occurred.Vascular access was obtained via crossover approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After the lesion was crossed with a thruway guidewire and pre-dilated with a 4mm balloon, a 6mm x 120mm and 7mm x 120mm eluvia stents were implanted.A 6.0x150x150 sterling balloon catheter was advanced for post-dilation but severe resistance was encountered when the balloon started to come out from the tip of the 6fr non-bsc sheath and it could not be delivered smoothly into the stent.Delivery was performed while resistance was felt, and inflation of the balloon was performed about 3 times.However, during removal, the balloon was stuck with the guide wire and it could not be removed.Subsequently, the device was removed as a set with the guidewire and the procedure was completed.No patient complications nor injuries 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
MDR Report Key11362093
MDR Text Key233050429
Report Number2134265-2021-02151
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729845447
UDI-Public08714729845447
Combination Product (y/n)N
PMA/PMN Number
K132430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2021
Device Model Number24715
Device Catalogue Number24715
Device Lot Number0025479424
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Date Manufacturer Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: THRUWAY 18; GUIDEWIRE: THRUWAY 18; INTRODUCER SHEATH: PARENT 6FR; INTRODUCER SHEATH: PARENT 6FR; STENT: ELUVIA 6X120 AND 7X120; STENT: ELUVIA 6X120 AND 7X120
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