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

Model Number 72404127

Device Problems Inflation Problem (1310); Difficult or Delayed Activation (2577)

Patient Problem Urinary Incontinence (4572)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

The implant date and lot number of the concomitants were unable to be obtained though good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.

Event Description

It was reported that the patient presented with recurring incontinence with an artificial urinary sphincter (aus).The existing device had worked initially, but eventually the incontinence returned.The physician attempted to cycle the device and refill the pump, but the issue was not identified and not resolved.The aus pump and balloon were explanted and replaced with a new pump and balloon.No additional patient complications were reported.

Event Description

It was reported that the patient presented with recurring incontinence with an artificial urinary sphincter (aus).The existing device had worked initially, but eventually the incontinence returned.The physician attempted to cycle the device and refill the pump, but the issue was not identified and not resolved.The aus pump and balloon were explanted and replaced with a new pump and balloon.No additional patient complications were reported.

Manufacturer Narrative

The implant date and lot number of the concomitant products were unable to be obtained though good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.Upon receipt at our post market quality assurance laboratory, the returned components underwent thorough analysis.The balloon was examined visually and microscopically and no damage was noted.The balloon passed leak testing but did not perform within pressure specification during functional testing.No pump issues were identified via visual or microscopic testing and the pump passed leak testing.No functional testing was performed on the pump due to the confirmed balloon pressure issue.Review of the manufacturing documentation did not find any evidence that the device failed to meet product specifications prior to shipment.The labelling review and risk review did not find any evidence that the device was handled improperly and indicated that therapy response altered and urinary incontinence are included as harms in the instructions for use.Based on all available information it was determined that the reported clinical event was the likely result of the balloon not meeting pressure specifications which would impact device efficacy as reported.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE
• Type of Device: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14780009
• MDR Text Key: 294544619
• Report Number: 2124215-2022-22232
• Device Sequence Number: 1
• Product Code: EZY
• UDI-Device Identifier: 00878953003078
• UDI-Public: 00878953003078
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P000053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 72404127
• Device Catalogue Number: 72404127
• Device Lot Number: 1000352345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON: UPN: 72400024 LOT#: 1000329192; BALLOON: UPN: 72400024 LOT#: 1000329192; CUFF: UPN: 72404131 LOT#: 1000294792; CUFF: UPN: 72404131 LOT#: 1000294792
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male