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

Model Number M0061752630

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used in a bilateral kidney and ureteric stone removal procedure in the ureter and kidney performed on (b)(6) 2021.Post procedure, on (b)(6) 2021, a planned stent removal procedure was performed to remove the implanted left side stent.The suture string that was attached to the stent was pulled but the string snapped when the nurse attempted to pull it out.A flexible cystoscopy was performed to remove the stent and the patient was discharged.The patient later complained of severe ongoing left sided pain and therefore a ct scan was organized which identified the left stent was still implanted in the patient.The right sided stent had been removed instead.The patient had his left sided stent removed successfully after the ct scan.There was no information if a new stent has been placed.There has experienced pain and discomfort reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: PERCUFLEX PLUS
• 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 Key: 13122111
• MDR Text Key: 285394911
• Report Number: 3005099803-2021-08073
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0025122839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention