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

Model Number	M0067201010
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 system was unpacked for a procedure on an unknown date.According to the complainant, during preparation, a black like deposit that seemed to be a dirt was noted in the protective cover of the device.The procedure was completed with another single action pump system.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 single action pump system was unpacked for a procedure on an unknown date.According to the complainant, during preparation, a black like deposit that seemed to be a dirt was noted in the protective cover of the device.The procedure was completed with another single action pump system.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Problem code 2944 captures the reportable event of foreign matter.Investigation result: visual examination of the complaint device revealed that the device does not have visual defects.A functional evaluation was performed by inserting the inlet tubing into water and depressing the syringe plunger to bleed all air out of the system.Water was then pulled through the system inlet tubing and expelled through the outlet tube.The roller clamp was moved to the open position and water was noted to flow through the system.The roller clamp was then moved to the closed position and no water was noted to flow through the system.No issues/leakages were noted.The returned device passes visual and functional tests, consequently, not confirming the reported complaint.Therefore the most probable root cause for this complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 8400229
• Report Number: 3005099803-2019-01126
• Device Sequence Number: 1990990
• Product Code: KOD
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: 10/21/2022
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0022826803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1