MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROVAC BLADDER EVACUATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0067301250
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	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(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 urovac bladder evacuator was unpacked on an unknown date.According to the complainant, during the preparation, a foreign object was found inside the device.The procedure was completed with another urovac bladder evacuator device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6)2020 as no event date was reported.Block h6: problem code 2969 captures the reportable issue of foreign matter.Block h10: investigation results a visual examination of the returned complaint device found a foreign material embedded in the wall of the bottle of the device, thereby confirming the reported event.A dimensional analysis was performed to the fm using a tappi chart, and it was noticed that the device is out of specification.The most probable root cause is manufacturing deficiency, as the reported failure was traced to the manufacturing process.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 urovac bladder evacuator was unpacked on an unknown date.According to the complainant, during the preparation, a foreign object was found inside the device.The procedure was completed with another urovac bladder evacuator device.There were no patient complications reported as a result of this event.

• Brand Name: UROVAC BLADDER EVACUATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10282960
• Report Number: 3005099803-2020-02794
• Device Sequence Number: 11407509
• Product Code: KQT
• UDI-Device Identifier: 08714729753018
• UDI-Public: 08714729753018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 01/09/2024
• Device Model Number: M0067301250
• Device Catalogue Number: 730-125S
• Device Lot Number: 0025020483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1