MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL

Model Number	M0067201011
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	10/01/2020
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.The complainant was unable to report the device lot number; therefore, the manufacture and expiration dates are unknown.(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 system was unpacked for a procedure on an unknown date.According to the complainant, during preparation, it was noticed that a hair was included in the package.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
Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block h2: additional information: block b5 (describe event or problem), d4 (lot number, expiration date), h4 (manufacture date).Block h6: problem code 2969 captures the reportable event of foreign matter in the packaging.Block h10: investigation result: 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 system was unpacked for a procedure on an unknown date.According to the complainant, during preparation, it was noticed that a hair was included in the package.The procedure was completed with another single action pump system.There were no patient complications reported as a result of this event.The device was unpacked for a transurethral lithotripsy (tul) procedure to be used in the urethra.Additionally, there was no damage noted in the device packaging.

• Brand Name: IRRIGATION
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10851207
• Report Number: 3005099803-2020-05505
• Device Sequence Number: 3234433
• Product Code: KQT
• UDI-Device Identifier: 08714729045076
• UDI-Public: 08714729045076
• 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): 12/10/2020

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: 07/21/2024
• Device Model Number: M0067201011
• Device Catalogue Number: 720-101S
• Device Lot Number: 0025752220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1