MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number M0067913500

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to provide the suspect device lot number.Therefore, the lot expiration and device manufacture dates are unknown.(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 lithovue flexscope was used during a ureteroscopy procedure.The exact procedure date was not reported.According to the complainant, upon preparation, the physician opened the scope out of the box and it looked like the packaging might have been torn.It was suspected that the sterile barrier might have been breached.The procedure was completed with another lithovue flexscope with no patient complications.Additionally, it was noted that there was no visible damage to the outer packaging of the device.

• Brand Name: LITHOVUE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 100 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 9377623
• MDR Text Key: 187066870
• Report Number: 3005099803-2019-05798
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

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
• Device Operator: Health Professional
• Device Model Number: M0067913500
• Device Catalogue Number: 791-350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1