MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404287
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, the patient complained that the cylinders could not be inflated due to fluid loss.The patient had the inflatable penile prosthesis removed and damage to one cylinder was detected, although the physician was unable to pinpoint the cause of the fluid loss.A new inflatable penile prosthesis was implanted, the patient was stable following the surgery and the event resolved.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient complained that the cylinders could not be inflated due to fluid loss.The patient had the inflatable penile prosthesis removed and damage to one cylinder was detected, although the physician was unable to pinpoint the cause of the fluid loss.A new inflatable penile prosthesis was implanted, the patient was stable following the surgery and the event resolved.
Additional Manufacturer Narrative
H3 device evaluation: the ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested.No leaks were found; the pump performed within specification.The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 has a pinhole leak in the proximal cylinder body that was result of sharp instrument damage which likely occurred during explant damage, and were considered a secondary failure.A small hole and tool marking were present.Cylinder 2 has a large tear in the outer tube at the proximal cylinder body that was result of wear against the krt.The cylinder also has a fatigue leak in the inner tube with broken fabric treads in the proximal cylinder body; hole was present.The krt of both cylinders were worn to filament; no leak was found in krt.The identified fluid leak in the inner tube with broken fabric treads is the most probable cause of the reported inflation issue, as the device would not be functional after the system fluid was lost.Product analysis confirmed that reported event.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10258124
• Report Number: 2183959-2020-02869
• Device Sequence Number: 2603666
• Product Code: FHW
• UDI-Device Identifier: 00878953003900
• UDI-Public: 00878953003900
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 05/23/2018
• Device Model Number: 72404287
• Device Catalogue Number: 72404287
• Device Lot Number: 831684002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOT # 188516012RESERVOIR; LOT # 188516012RESERVOIR; LOT # 188516012RESERVOIR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention