MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW; CATHETER, UROLOGICAL

Model Number	M0067201011
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a transurethral urinary tract stone removal procedure, a single action pump was setup, and a piece of vinyl was found in the lumen of the sealed syringe.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a180104 captures the reportable event of foreign material present in the device.
Event or Problem Description
It was reported that during a transurethral urinary tract stone removal procedure, a single action pump was setup, and a piece of vinyl was found in the lumen of the sealed syringe.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Device code a180104 captures the reportable event of foreign material present in the device.The returned irrigation was analyzed, and a visual evaluation noted that the tubing set was free of obvious kinks and the roller clamp was found in an open position.It was also noted that the grommets returned together and there was no evidence of fluid indicating the device was not used.Media analysis was performed from the pictures provided by the customer and shows the irrigation syringe with a foreign matter inside.Microscopic examination was performed, and it was possible to see that there was evidence of foreign matter inside the syringe.Additionally, materials testing analysis and characterization (mtac) analysis determine that the foreign material found inside the syringe was a kind of silicone.Boston scientific concludes that the reported event was confirmed.Based on analysis results, an investigation conclusion code of manufacturing deficiency was assigned to this investigation.

• Brand Name: SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19744117
• Report Number: 2124215-2024-43526
• Device Sequence Number: 7720321
• Product Code: KOD
• UDI-Device Identifier: 08714729045076
• UDI-Public: 08714729045076
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K870557
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: M0067201011
• Device Catalogue Number: 720-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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