MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGID URETERAL DILATORS AND SHEATHS; ACCESSORIES, CATHETER, G-U

Model Number	M0062501000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 rigid ureteral dilator and sheath was used during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician attempted to dilate around a semi-large stone.However, upon withdrawing the dilator, it broke in half.Reportedly, he went back and retrieved the device with a grasper.The procedure was completed at this time.There have been no patient complications reported as a result of this event.

• Brand Name: RIGID URETERAL DILATORS AND SHEATHS
• Common Device Name: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8960287
• Report Number: 3005099803-2019-04380
• Device Sequence Number: 2823917
• Product Code: EZN
• UDI-Device Identifier: 08714729005322
• UDI-Public: 08714729005322
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K851144
• 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): 09/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2023
• Device Model Number: M0062501000
• Device Catalogue Number: 240-100
• Device Lot Number: 0023542356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/04/2019
• 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