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

Model Number	72400170
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that due to erosion of the cuff through the vaginal wall and a pin point leak in the cuff, the patient had his artificial urinary sphincter (aus) 9.0 cm cuff removed.The surgeon left the balloon and pump still implanted inside the patient.The surgeon repaired the tissue at the erosion location.The physician stated that in 2 months the patient will be re-implanted with a new cuff.It was further reported that the because of the erosion was due to the patient's previous surgeries and cancer treatment, and the physician believes the erosion occurred due to very thin vaginal wall tissue under pressure by the bladder neck." the onset of the erosion is unknown and there were patient symptoms related to the fluid leak in cuff.The patient is stable after this surgery but it without any cuff connected to the implanted system due to the removal of the cuff.The physician repaired the eroded tissue and will be given several months to heal before implanting a new cuff.
Additional Manufacturer Narrative
A perforation and fluid loss were reported.The ams800 occlusive cuff was visually inspected and microscopically examined.The cuff was measured, and the device size was consistent with the reported information.There was a pinhole leak in the occlusive cuff shell.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Analysis confirmed the fluid loss due to wear.However, the erosion is unable to be confirmed.Correction to if follow-up, what type, device evaluated by mfr: updated to include device analysis.
Event or Problem Description
It was reported that due to erosion of the cuff through the vaginal wall and a pin point leak in the cuff, the patient had his artificial urinary sphincter (aus) 9.0 cm cuff removed.The surgeon left the balloon and pump still implanted inside the patient.The surgeon repaired the tissue at the erosion location.The physician stated that in 2 months the patient will be re-implanted with a new cuff.It was further reported that the because of the erosion was due to the patient's previous surgeries and cancer treatment, and the physician believes the erosion occurred due to very thin vaginal wall tissue under pressure by the bladder neck." the onset of the erosion is unknown and there were patient symptoms related to the fluid leak in cuff.The patient is stable after this surgery but it without any cuff connected to the implanted system due to the removal of the cuff.The physician repaired the eroded tissue and will be given several months to heal before implanting a new cuff.

• 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: 9245639
• Report Number: 2183959-2019-67121
• Device Sequence Number: 14090787
• Product Code: EZY
• UDI-Device Identifier: 00878953000800
• UDI-Public: 00878953000800
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 11/26/2022
• Device Model Number: 72400170
• Device Catalogue Number: 72400170
• Device Lot Number: 1000013507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR