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

Model Number	72400164
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Swelling (2091)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional components: model/catalog description: control pump fgs, model number: 72400098, batch/lot number: 1000102169.Model/catalog description: balloon fgs 61-70cm, model number: 72400024, batch/lot number: 1000093047.
Event or Problem Description
It was reported that the patient had an artificial urinary sphincter explanted and replaced due to scrotal mass infection and the belt cuff erosion through the urethra.Further information was requested and not yet received.
Event or Problem Description
It was reported that the patient experienced scrotal mass infection and belt cuff erosion through the urethra with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon were explanted and a new 6.0cm aus cuff, pump, and balloon were implanted.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: the reported allegation(s) could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.Bsc aware date.Additional components: model/catalog description: control pump fgs model number: 72400098 batch/lot number: 1000102169 model/catalog description: balloon fgs 61-70cm model number: 72400024 batch/lot number: 1000093047this supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 06:57 pm ct.The report number is being corrected from: 2183959-2018-61670to: 2183959-2018-60597.
Additional Manufacturer Narrative
(b)(4).Additional components: model/catalog description: control pump fgs, model number: 72400098, batch/lot number: 1000102169.Model/catalog description: balloon fgs 61-70cm, model number: 72400024, batch/lot number: 1000093047.
Event or Problem Description
It was reported that the patient experienced scrotal mass infection and belt cuff erosion through the urethra with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon were explanted and a new 6.0cm aus cuff, pump, and balloon were implanted.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: bsc aware date.Additional components: model/catalog description: control pump fgs model number: 72400098 batch/lot number: 1000102169 model/catalog description: balloon fgs 61-70cm model number: 72400024 batch/lot number: 1000093047.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 06:57 pm ct.The report number is being corrected from: 2183959-2018-61670to: 2183959-2018-60597.
Event or Problem Description
It was reported that the patient experienced scrotal mass infection and belt cuff erosion through the urethra with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon were explanted and a new 6.0cm aus cuff, pump, and balloon were implanted.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient experienced scrotal mass infection and belt cuff erosion through the urethra with an artificial urinary sphincter (aus).The aus cuff, pump, and balloon were explanted and a new 6.0cm aus cuff, pump, and balloon were implanted.Should additional relevant details become available, a supplemental report will be submitted.Additional information was reported that the aus cuff, pump, and balloon was only implanted and no new device was implanted.
Additional Manufacturer Narrative
Additional information was reported that the aus cuff, pump, and balloon was only implanted and no new device was implanted.Additional information: the reported allegation(s) could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.Bsc aware date.Additional components: model/catalog description: control pump fgs model number: 72400098, batch/lot number: (b)(4), model/catalog description: balloon fgs 61-70cm, model number: 72400024, batch/lot number: (b)(4).This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/13/2018 06:57 pm ct.The report number is being corrected from: 2183959-2018-61670 to: 2183959-2018-60597.

• 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: 8021823
• Report Number: 2183959-2018-60597
• Device Sequence Number: 1131586
• Product Code: EZY
• UDI-Device Identifier: 00878953000756
• UDI-Public: 00878953000756
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/29/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/05/2022
• Device Model Number: 72400164
• Device Catalogue Number: 72400164
• Device Lot Number: 0173541009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 10/02/2018; 02/01/2019; 04/15/2019
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/10/2018; 01/25/2019; 02/26/2019; 04/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR