MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-26 for AMS 800 URINARY CONTROL SYSTEM 72400024 manufactured by Boston Scientific Corporation.
[185906852]
Device analysis: an allegation of a hole causing fluid loss was reported. The ams 800 balloon was visually inspected. Upon microscopic examination, a small tear was noticed in the balloon sphere at the adapter junction. A leakage test was performed, and fluid loss occurred as a result of the tear. It was determined that the damage to the balloon is consistent with material fatigue. The perforation and leak would directly affect the overall functionality of the device and would therefore conclude as the most probable cause of the reported issues. Product analysis identified a tear in the balloon shell; the reported events were therefore confirmed. The product record review indicated that the reported events do not represent an unanticipated event. Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed. Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure through product investigation. Based on the results of this investigation, no escalation is required.
Patient Sequence No: 1, Text Type: N, H10
[185906853]
It was reported that the patient underwent a revision procedure due to fluid loss with an artificial urinary sphincter (aus). The aus cuff, pump, and balloon was explanted and a new aus cuff, pump, and balloon was implanted. During the revision procedure the physician observed the balloon was leaking through a hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2020-01626 |
| MDR Report Key | 9882732 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-09-10 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALYSON HARRIS |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 4089353452 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 800 URINARY CONTROL SYSTEM |
| Generic Name | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC |
| Product Code | EZY |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 72400024 |
| Catalog Number | 72400024 |
| Lot Number | 1000329210 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-26 |