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 Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.  (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 an unknown date.According to the complainant, while unpacking, a hair like object was found inside the packaging.The procedure was completed with another saps device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 as no event date was reported.  (b)(4).A visual examination of the returned complaint device did not show visual defects, the device was closed/sealed and packaged inside its original pouch.The sealed section of the returned pouch looks good and without damages; however, a small hair was found to be inside the pouch.No other issue was noted.Based on the condition and evaluation of the returned device, the most probable root cause is manufacturing deficiency since the issue was traced to the manufacturing process.An investigation to address this issue has been completed.
Event or Problem Description
It was reported to boston scientific corporation that a single action pumping system (saps) was unpacked on an unknown date.According to the complainant, while unpacking, a hair like object was found inside the packaging.The procedure was completed with another saps device.There were no patient complications reported as a result of this event.

• Brand Name: IRRIGATION
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8064105
• Report Number: 3005099803-2018-61336
• Device Sequence Number: 1582356
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 06/17/2022
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0022266713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1