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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC
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BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Model Number 1094-01
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/20/2023
Event Type  Injury  
Event Description
It was reported that the suture remained in the patient.A flexima ureteral stent system was inserted for drainage of the ureter.During removal of the device, at the end of the procedure, the locking suture could not be removed.The suture was cut at the string entry point and remained in the patient.
 
Manufacturer Narrative
H6 - impact codes: corrected from 'insufficient information' to 'serious injury/illness/impairment'.
 
Event Description
It was reported that the suture remained in the patient.A flexima ureteral stent system was inserted for drainage of the ureter.During removal of the device, at the end of the procedure, the locking suture could not be removed.The suture was cut at the string entry point and remained in the patient.
 
Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis was completed.Visual analysis revealed that only the proximal section of the suture string was returned for analysis.The suture string was separated from the device.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No other issues were observed in the device.
 
Event Description
It was reported that the suture remained in the patient.A flexima ureteral stent system was inserted for drainage of the ureter.During removal of the device, at the end of the procedure, the locking suture could not be removed.The suture was cut at the string entry point and remained in the patient.
 
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Brand Name
FLEXIMA
Type of Device
TUBE, DRAINAGE, SUPRAPUBIC
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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18334429
MDR Text Key330595317
Report Number2124215-2023-69872
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729323778
UDI-Public08714729323778
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K944290
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1094-01
Device Catalogue Number1094-01
Device Lot Number0029724493
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2022
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 Outcome(s) Other;
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