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

Model Number	72400167
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product component: model number/catalog number: 72400024 and 72400098, serial number: null and null, batch/lot number: 119240011 and 114651003, model/catalog description: balloon fgs 61-70cm and control pump fgs.
Event or Problem Description
It was reported that the patient experienced recurring incontinence with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
Additional Manufacturer Narrative
Device analysis: recurring incontinence was reported.The ams800 occlusive cuff was visually inspected.There was a leak in the occlusive cuff shell that was the result of wear at a fold.An overall investigation conclusion code of cause traced to component failure was chosen as the analysis findings and event are an expected or random component failure without any design or manufacturing issue.See external support request form 92379044.No escalation to ncep, capa, or scar is required, complaints are monitored for escalation of systemic issues through the trending process per the cis product investigation work instruction.Balloon analysis: recurring incontinence was reported.The ams800 balloon was visually inspected and functionally tested.No leak was found.The balloon performed within specifications.Pump analysis: as the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.An overall investigation conclusion code of known inherent risk of device was chosen as the reported adverse event is known and documented in the labeling.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.Additional product component: model number/catalog number: 72400024 and 72400098, serial number: null and null, batch/lot number: 119240011 and 114651003, model/catalog description: balloon fgs 61-70cm and control pump fgs.
Event or Problem Description
It was reported that the patient experienced recurring incontinence with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
Additional Manufacturer Narrative
Device analysis: recurring incontinence was reported.The ams800 occlusive cuff was visually inspected.There was a leak in the occlusive cuff shell that was the result of wear at a fold.An overall investigation conclusion code of cause traced to component failure was chosen as the analysis findings and event are an expected or random component failure without any design or manufacturing issue.See external support request form 92379044.No escalation to ncep, capa, or scar is required, complaints are monitored for escalation of systemic issues through the trending process per the cis product investigation work instruction additional product component: model number/catalog number: 72400024 and 72400098, serial number: null and null, batch/lot number: 119240011 and 114651003, model/catalog description: balloon fgs 61-70cm and control pump fgs.
Event or Problem Description
It was reported that the patient experienced recurring incontinence with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

• 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: 8416719
• Report Number: 2183959-2019-61498
• Device Sequence Number: 13831835
• Product Code: EZY
• UDI-Device Identifier: 00878953000787
• UDI-Public: 00878953000787
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/26/2018
• Device Model Number: 72400167
• Device Catalogue Number: 72400167
• Device Lot Number: 845788003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 06/18/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 06/10/2019; 06/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR