MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0067913600

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18. The device has been received for analysis; however the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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.

Event Description

It was reported to boston scientific corporation that a lithovue standard deflection scope was used in the kidney during a nephroscopy procedure performed on (b)(6) 2018. According to the complainant, during procedure, a foreign object that looks like a ¿jelly roll¿ was lodged in the patient and was seen by the physician inside the working channel of the scope. Reportedly, the object does not look like a part of any device. The foreign object was retrieved upon withdrawal of the lithovue scope however it was not retained. A different device was used to complete the procedure. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be stable. Additionally, the patient had previous surgical procedures. Last (b)(6) 2018, the patient had nephrostomy with stent insertion due to 10 mm stone. On (b)(6) 2018, the patient had a left sided rigid ureteroscopy with disintegration and extraction of stone fragments and the recent procedure on (b)(6) 2018 for a ureteroscopy to extract 4 mm stone fragment from lower renal calyx.

Manufacturer Narrative

Additional information received on 02jul2018. A lithovue single-use digital flexible ureteroscope was returned for evaluation. Visual examination revealed that the black covering of the active deflection section appeared to have fallen off. Additional examination on the black covering revealed that the composition does not match with the foreign matter reported by the customer which was "diaphanous" and ¿jelly roll¿. There was no foreign material found inside or pushed out of the working channel upon disinfection. It is likely that the foreign matter reported by the customer was a component from the inner lumen of the navigator hd access sheath used by the customer without lubricant. It is also likely that matter emerging through the access sheath, such as a component of the access sheath that rubbed off would appear like matter emerging through the working channel, as described by the customer. Based on all gathered information, the noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device. Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context. A review of the device history record (dhr) was performed; no anomalies were noted. A search of the complaint database revealed that no similar complaints exist for the specified lot. A labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a lithovue standard deflection scope was used in the kidney during a nephroscopy procedure performed on (b)(6) 2018. According to the complainant, during procedure, a foreign object that looks like a ¿jelly roll¿ was lodged in the patient and was seen by the physician inside the working channel of the scope. Reportedly, the object does not look like a part of any device. The foreign object was retrieved upon withdrawal of the lithovue scope however it was not retained. A different device was used to complete the procedure. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be stable. Additionally, the patient had previous surgical procedures. Last (b)(6) 2018, the patient had nephrostomy with stent insertion due to 10 mm stone. On (b)(6) 2018, the patient had a left sided rigid ureteroscopy with disintegration and extraction of stone fragments and the recent procedure on may 2018 for a ureteroscopy to extract 4 mm stone fragment from lower renal calyx. Additional information received 02jul2018. A navigator access sheath was used together with the lithovue scope and no lubricant was used during the procedure. The color of the foreign object was observed to be diaphanous, close to white.

• Brand Name: LITHOVUE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7633938
• MDR Text Key: 112176988
• Report Number: 3005099803-2018-02093
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/02/2020
• Device Model Number: M0067913600
• Device Catalogue Number: 791-360
• Device Lot Number: 21943952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/25/2018 Patient Sequence Number: 1