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

Model Number	M006175252050
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(6).(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a right nefrolitotripsia procedure in the ureter, performed on (b)(6), 2020.According to the complainant, during the procedure and inside the patient, when the physician attempted to insert the stent through the urethra, it was noticed that the stent broke on one side.The broken piece was retrieved using a foreign body clamp.No fragments were left inside the patient.Another percuflex stent 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.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6) block h6: device code 2976 captures the reportable event of stent kink inside patient.Block h10: the returned percuflex ureteral stent was analyzed, and a visual evaluation noted that the stent proximal, bladder pigtail, section was found buckled/accordion.A functional evaluation noted that, a mandrel 0.035" were inserted through the catheter and no resistance was felt.No other issues were noted with the device.The reported event was confirmed.The stent proximal, bladder pigtail, was found buckled/accordion which could be interpreted by the customer as kinked.According to the product analysis, the device has the catheter buckled (bladder pigtail section), however, this failure is known to be generated due to the force used when the stent is pushed up with the pusher/positioner over the guidewire or when the stent was removed, moreover, the device was received without the suture string, this is evidence that the device was manipulated; therefore, it is the most likely that it was generated due to the manipulation of the device or due to the interaction with other devices during the procedure.It's important to mention that during product analysis the device was tested and mandrel 0.035" were inserted through the catheter and no resistance was felt.It's important to mention that no sections detached were identify in 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additional information: a2 (age at time of event) and b5 (event description) block h11: correction: b1 (adverse event/product problem), b2 (outcomes attrib to adv event), and h1 (type of reportable event).
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a right nefrolitotripsia procedure in the ureter, performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, when the physician attempted to insert the stent through the urethra, it was noticed that the stent kinked on the bladder side.The entire stent was removed using a foreign body clamp.Another percuflex stent 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.** additional information received on (b)(6) 2020 ** according to the complainant, during the procedure and inside the patient, when the physician attempted to insert the stent through the urethra, it was noticed that the stent kinked on the bladder side.The entire stent was removed using a foreign body clamp.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10219718
• Report Number: 3005099803-2020-02498
• Device Sequence Number: 3233147
• Product Code: FAD
• UDI-Device Identifier: 08714729339960
• UDI-Public: 08714729339960
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: M006175252050
• Device Catalogue Number: 175-252-05
• Device Lot Number: 0025161166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/04/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 76