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

Model Number M006175252050

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10219718
• MDR Text Key: 197182575
• Report Number: 3005099803-2020-02498
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729339960
• UDI-Public: 08714729339960
• Combination Product (y/n): N
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 76