MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063901010
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patients exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip stone retrieval basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a zero tip basket was used in an attempt to remove multiple stones.However, the basket became stuck in the ureter with a stone inside, and the basket was unable to open or close.The basket was cut to remove the flexible ureteroscope.A semi rigid ureteroscope was then used with a laser to remove the basket.One of the basket wires was left in the patient and was then extracted using a dakota basket.The procedure was completed with a different device.No patient complications were reported due to this event.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: ZERO TIP
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9587337
• Report Number: 3005099803-2019-06509
• Device Sequence Number: 14072015
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: 08714729342007
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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: 08/19/2021
• Device Model Number: M0063901010
• Device Catalogue Number: 390-101
• Device Lot Number: 0022534611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/14/2020
• 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: Required Intervention