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

Model Number	M006175263010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a stent replacement procedure in the ureter, performed on "(b)(6) 2021".During the procedure and inside the patient, when the physician deployed the stent and removed the guidewire, it was noticed that a piece of the stent broke.No other device was used to grasp the broken piece of stent.Another percuflex plus was opened and successfully completed the procedure.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.A photo of the complaint device was provided and showed that a piece of the stent coil was detached/separated.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of coil detachment of device or device component inside the patient.Block h10: the returned percuflex plus ureteral was analyzed, and a visual evaluation noted that the bladder pig tail was detached separate in 2 section.The suture string, the positioner and stabilizer did not return for the analysis.A photo was also attached in the complaint record.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it is possible that operational factors, such as interacting of the device with the suture string, manipulation or excess of force applied during it use, could have caused the detached observed.Consequently affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a stent replacement procedure in the ureter, performed on (b)(6) 2021.During the procedure and inside the patient, when the physician deployed the stent and removed the guidewire, it was noticed that a piece of the stent broke.No other device was used to grasp the broken piece of stent.Another percuflex plus was opened and successfully completed the procedure.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.A photo of the complaint device was provided and showed that a piece of the stent coil was detached/separated.

• 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: 13196991
• Report Number: 3005099803-2022-00012
• Device Sequence Number: 6071297
• Product Code: FAD
• UDI-Device Identifier: 08714729302032
• UDI-Public: 08714729302032
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 08/02/2024
• Device Model Number: M006175263010
• Device Catalogue Number: 175-263-01
• Device Lot Number: 0028248457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 54 KG