MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M006175263190
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Medical device problem code a0501 captures the reportable investigation result of stent shaft detached.The returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that stent shaft was detached.The suture and positioner were not returned; however, the stabilizer and collar were returned in good conditions.For the functional test use a mandrel of 0.039" and pass through the stent without resistance.No other problems with the device were noted.The reported event was not confirmed.According to the product analysis, 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 that device is detached inside the shaft.Additionally, the suture was not returned, indicating that it was removed, and 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.Consequently, affect the performance of the device.The coil detachment of device or device component was not confirmed due to a detached in the coil was not detected during the analysis and neither a related issue with the reported allegation, additionally, the device was found detached in their shaft and not in their coils.Therefore, the most probable cause of this complaint is adverse event related to procedure.
Event or Problem Description
Procedure summary: it was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral stent placement in the ureter performed on (b)(6) 2022.Event summary: during preparation, it was found that the pigtail was broken.Another percuflex plus ureteral stent was opened and successfully completed the procedure.Additional information: investigation results revealed the stent shaft was broken, therefore this event has been deemed a reportable event.Patient status: there were no patient complications reported as a result of this event.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: 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 Key: 16299730
• Report Number: 3005099803-2023-00367
• Device Sequence Number: 6802880
• Product Code: FAD
• UDI-Device Identifier: 08714729772996
• UDI-Public: 08714729772996
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2025
• Device Model Number: M006175263190
• Device Catalogue Number: 175-263-19
• Device Lot Number: 0029782471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown