MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL

Model Number	M0067201010
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	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 single action pump was intended to be used in the upper urinary tract in a transurethral lithotripsy (tul) procedure performed on (b)(6) 2021.During preparation outside the patient, when they tried to open the individual packaging of single action pump system (saps), it was noticed that there was a small brown foreign substance inside the packaging of the device and so they decided not to use the device.The procedure was completed with another single action pump.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer showing a small brown substance inside the packaging of the device.
Additional Manufacturer Narrative
Block h6: medical device problem code a1802 captures the reportable event of presence of foreign matter inside the device packaging.Block h10: investigation results: a photo was submitted by the customer showing the device with a foreign matter in its pouch packaging.Visual examination of the returned complaint device found that a foreign matter was inside the pouch.A dimensional examination of the foreign matter was performed and it was measured as loose particulate and round product or component with a size bigger than the allowable size of 0.20 mm.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.An investigation to address this issue has been completed.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 single action pump was intended to be used in the upper urinary tract in a transurethral lithotripsy (tul) procedure performed on (b)(6) 2021.During preparation outside the patient, when they tried to open the individual packaging of single action pump system (saps), it was noticed that there was a small brown foreign substance inside the packaging of the device and so they decided not to use the device.The procedure was completed with another single action pump.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer showing a small brown substance inside the packaging of the device.

• Brand Name: IRRIGATION
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12495029
• Report Number: 3005099803-2021-04893
• Device Sequence Number: 11709297
• Product Code: KQT
• UDI-Device Identifier: 08714729752998
• UDI-Public: 08714729752998
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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 Expiration Date: 05/23/2025
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0027373540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1