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

Model Number	M0062401000
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to 01/01/2021 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 or Problem Description
Reported to boston scientific corporation that a rigid ureteral dilators and sheaths was used for a procedure on an unknown date.According to the complainant, the device came with a finger of a glove inside of the packaging was noticed as confirmed by a photo of the complaint device submitted by the customer.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 11300948
• Report Number: 3005099803-2021-00463
• Device Sequence Number: 5035841
• Product Code: EZN
• UDI-Device Identifier: 08714729005322
• UDI-Public: 08714729005322
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K851144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: M0062401000
• Device Catalogue Number: 240-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/09/2021
• Patient Sequence Number: 1