MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 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	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.(b)(4).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 pumping system (saps) was unpacked on (b)(6) 2017.According to the complainant, during unpacking, a pen was found inside the sterile packaging.The procedure was completed with another saps device.There were no patient complications reported as a result of this event.Regarding the patient¿s condition at the conclusion of the procedure, it was noted that there were no adverse events.
Additional Manufacturer Narrative
Investigation result: the complaint device was not returned and only the device original sterile pouch which was found to be opened and with a pen inside was returned for inspection.As the device was received with the packaging having already been opened, the noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a single action pumping system (saps) was unpacked on (b)(6) 2017.According to the complainant, during unpacking, a pen was found inside the sterile packaging.The procedure was completed with another saps device.There were no patient complications reported as a result of this event.Regarding the patient¿s condition at the conclusion of the procedure, it was noted that there were no adverse events.

• Brand Name: SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; propark free zone; spencer IN 47460
• MDR Report Key: 7112022
• Report Number: 3005099803-2017-03609
• Device Sequence Number: 1156751
• Product Code: KOD
• UDI-Device Identifier: 08714729045076
• UDI-Public: 08714729045076
• Combination Product (Y/N): N
• 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): 11/20/2017

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: 09/28/2021
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 21193182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1