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	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a dilator sheath set was about to be used prior to procedure on (b)(6) 2022.Prior to procedure, the product was never used or opened; however, a black hair was noticed inside the sterile packaging.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a dilator sheath set was about to be used prior to procedure on (b)(6), 2022.Prior to procedure, the product was never used or opened; however, a black hair was noticed inside the sterile packaging.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6) block e1: this event was reported by the distributor.The health care facility is: (b)(6) block h6: medical device code a1802 captures the reportable event of foreign material.Block h10: investigation result the returned dilator sheath set was analyzed, and a visual evaluation found a hair inside of the unopened pouch.The pouch was returned closed and in a good condition.No other problems with the device were noted.The reported event of foreign material present on the device was confirmed.Investigation found that the pouch was returned unopened; however, a foreign matter was observed inside the pouch.Therefore, the most probable root cause of this event is manufacturing deficiency as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 14046141
• Report Number: 3005099803-2022-01690
• Device Sequence Number: 17573046
• Product Code: EZN
• UDI-Device Identifier: 08714729005551
• UDI-Public: 08714729005551
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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: 01/23/2026
• Device Model Number: M0062601200
• Device Catalogue Number: 260-120
• Device Lot Number: 0028735542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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