MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DUAL LUMEN URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064051000
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	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a dual lumen ureteral catheter was to be used in the kidney during a ureteroscopy procedure performed on (b)(6) 2022.During preparation, an eyelash was noticed inside the device packaging.The procedure was completed with another dual lumen ureteral catheter.Note: a photo was submitted by the customer showing an eyelash inside the device 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 dual lumen ureteral catheter was to be used in the kidney during a ureteroscopy procedure performed on (b)(6) 2022.During preparation, an eyelash was noticed inside the device packaging.The procedure was completed with another dual lumen ureteral catheter.Note: a photo was submitted by the customer showing an eyelash inside the device packaging.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a1802 captures the reportable event of foreign material present on the packaging.Block h10: investigation result: the returned dual lumen ureteral catheter was analyzed, and a visual evaluation found the device was returned inside the unopened pouch.Additionally, a foreign material was observed inside the pouch.A media analysis was performed to the photo provided by the customer which confirmed the foreign material inside the pouch.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.

• Brand Name: DUAL LUMEN URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• 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: 15447010
• Report Number: 3005099803-2022-05106
• Device Sequence Number: 20021330
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: 08714729012689
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K860337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 07/20/2026
• Device Model Number: M0064051000
• Device Catalogue Number: 405-100
• Device Lot Number: 0029806602
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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