MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 8/10 DILATOR/SHEATH SET; DILATOR, CATHETER, URETERAL

Model Number	M0062601200
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a nephrostomy sheath and dilators was used in the ureter during a transurethral stone crushing procedure performed on (b)(6) 2023.During the procedure, an insect corpse was found inside the device package.The procedure was completed with another nephrostomy sheath and dilator.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a1802 captures the reportable event of foreign matter inside the device package.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign matter inside the device package.Block h10: investigation results a visual examination of the returned nephrostomy sheaths and dilators found that the unopened pouch was found with a foreign matter in the outer side.No other problems with the device were noted.The reported event of foreign material present was confirmed.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a nephrostomy sheath and dilators was used in the ureter during a transurethral stone crushing procedure performed on (b)(6) 2023.During the procedure, an insect corpse was found inside the device package.The procedure was completed with another nephrostomy sheath and dilator.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: 8/10 DILATOR/SHEATH SET
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16529510
• Report Number: 3005099803-2023-01312
• Device Sequence Number: 2645227
• Product Code: EZN
• UDI-Device Identifier: 08714729005551
• UDI-Public: 08714729005551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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 Expiration Date: 06/12/2026
• Device Model Number: M0062601200
• Device Catalogue Number: 260-120
• Device Lot Number: 0029577214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown