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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION PERCUFLEX; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M0061453620
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a percuflex ureteral stent was opened on (b)(6) 2021.During unpacking, it was found that the stent became fractured.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the distal end of the stent shaft was broken.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).
 
Event Description
It was reported to boston scientific corporation that a percuflex ureteral stent was opened on (b)(6) 2021.During unpacking, it was found that the stent became fractured.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the distal end of the stent shaft was broken.
 
Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hosptal.Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Block h10: a photo of a percuflex ureteral stent was analyzed, and a visual evaluation noted that the bladder coil detached with their respective suture loaded and cut.No other problems with the device were noted.The reported event was not 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.It was found after the media analysis, that the bladder coil was detached.Additionally, their suture was observed loaded and cut, indicating that it was tried do be remove, which means that the stent was used.Therefore, 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.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
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 Key16064817
MDR Text Key307026824
Report Number3005099803-2022-07633
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729040330
UDI-Public08714729040330
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K834468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0061453620
Device Catalogue Number145-362
Device Lot Number0029837140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2022
Initial Date FDA Received12/28/2022
Supplement Dates Manufacturer Received12/19/2022
Supplement Dates FDA Received01/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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