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

Model Number	175-252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device code (b)(4) captures the reportable event of stent shaft broken.Conclusion code(b)(4) is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure in the ureter performed on (b)(6)2022.During the procedure, when the pusher was placed, the coil was positioned in the left ureter and in the right ureter it was crowded and neither the guide nor the pusher advanced, much less the fractionated catheter, the ureter of the patient with evidence of bleeding was removed with difficulty.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Update to block e1: initial reporter's name: dr.(b)(6).Initial reporter's phone number: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure in the ureter performed on (b)(6) 2022.During the procedure, when the pusher was placed, the coil was positioned in the left ureter and in the right ureter it was crowded and neither the guide nor the pusher advanced, much less the fractionated catheter, the ureter of the patient with evidence of bleeding was removed with difficulty.There were no patient complications reported as a result of this event.Additional information received that the patent is stable with reversible injury.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used during a ureteral lithiasis procedure in the ureter performed on (b)(6) 2022.During the procedure, when the pusher was placed, the coil was positioned in the left ureter and in the right ureter it was crowded and neither the guide nor the pusher advanced, much less the fractionated catheter, the ureter of the patient with evidence of bleeding was removed with difficulty.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 with reversible injury.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of stent shaft broken.Block h11: block b5 has been updated with procedure name.

• 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: 15090098
• Report Number: 3005099803-2022-03951
• Device Sequence Number: 12037668
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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,Followup,Followup
• Report Date (Section B): 10/25/2022

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: 05/20/2024
• Device Model Number: 175-252
• Device Catalogue Number: 175-252
• Device Lot Number: 0027354295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 09/30/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/19/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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 Sex: Unknown