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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M006175263010
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2023
Event Type  malfunction  
Event Description
It was reported that a percuflex plus ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6) 2023.During preparation, it was noted that the stent became broken when the suture was removed.It was reported that the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft broken.
 
Event Description
It was reported that a percuflex plus ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6) 2023.During preparation, it was noted that the stent became broken when the suture was removed.It was reported that the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Correction to device and component code: additional information received that the stent coil was detached.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was detached.The suture, positioner and the detached part was not returned, however their respective axxcess catheter and guidewire inside their original pouches were in good condition.A functional test was performed and used a mandrel of 0.039" and the stent pass through without resistance.During magnification, it was observed closely that the section of the device was detached.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the evidence, it is possible that operational factors, interaction of the excess force during interaction with the suture string such as an entanglement before their use could have caused the detachment that was observed.Consequently, affect the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
 
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Brand Name
PERCUFLEX PLUS
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key16535607
MDR Text Key311213810
Report Number3005099803-2023-01278
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729302032
UDI-Public08714729302032
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K924608
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM006175263010
Device Catalogue Number175-263-01
Device Lot Number0030115418
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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