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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 as no event date was reported.(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 for a urethral stone crushing procedure on an unknown date.According to the complainant, prior to the device packaging being opened, a piece of paper was found in the bag.The procedure was completed with another single action pump.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 was unpacked for a urethral stone crushing procedure on an unknown date.According to the complainant, prior to the device packaging being opened, a piece of paper was found in the bag.The procedure was completed with another single action pump.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to 01/01/2021 as no event date was reported.H6: problem code 2969 captures the reportable issue of foreign matter.H10: investigation results a visual examination of the returned complaint device found that the original pouch was completely sealed and the pouch did not present holes or cuts that could compromise sterility.Fibers/lint/dirt (residues) was found inside of the pouch sealed.Dimensional examination was also performed.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.

• Brand Name: IRRIGATION
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11236820
• Report Number: 3005099803-2021-00238
• Device Sequence Number: 11723036
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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 Expiration Date: 09/10/2024
• Device Model Number: M0067201010
• Device Catalogue Number: 720-101S
• Device Lot Number: 0026001543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1