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	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a single action pump was unpacked to be used in the ureter or the renal pelvis for a transurethral lithotripsy (tul) procedure performed on an unknown date.Prior to the procedure, a foreign matter was noted mixed in the sterilized bag.The procedure was completed with another single action pump.There were no patient complications reported as a result of this event.

• 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
• MDR Report Key: 12249340
• Report Number: 3005099803-2021-03874
• Device Sequence Number: 11484394
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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 Model Number: M0067201011
• Device Catalogue Number: 720-101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1