MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400165
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 6.5 cm belt cuff before implantation, it was noticed that was unable to normally fill with saline or aspirate the saline out of the cuff.It appears that something is blocking the tubing were the tubing and the cuff connects.After multiple filling and aspiration attempts, it was determined that the cuff was faulty.Therefore, a new cuff was opened and prepared to implant.The procedure was successfully completed without patient complications.
Event or Problem Description
It was reported that during preparation of the 6.5 cm belt cuff before implantation, it was noticed that was unable to normally fill with saline or aspirate the saline out of the cuff.It appears that something is blocking the tubing were the tubing and the cuff connects.After multiple filling and aspiration attempts, it was determined that the cuff was faulty.Therefore, a new cuff was opened and prepared to implant.The procedure was successfully completed without patient complications.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the an ams 800 occlusive cuff was thoroughly inspected and analyzed.The cuff component was visually inspected, microscopically examined, and tested for flow.A clear "gap" was identified in the cuff.Microscopic examination identified this as a silicone blockage.The flow test identified the occlusion indicated by decreased water flow through the cuff.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Product analysis identified a malfunction and confirmed the reported events.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10989125
• Report Number: 2183959-2020-05858
• Device Sequence Number: 629817
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: 00878953000763
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 03/05/2023
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 1000067297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1