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

Model Number	72404162
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis replaced due to fluid loss from the reservoir and the cylinders would not inflate.The reservoir had a visible hole resulting in fluid loss.Following the surgery, the patient was stable and well.The event resolved.
Additional Manufacturer Narrative
H3 device evaluation: the ams 700 spherical reservoir was visually inspected and functionally tested.There was a small leak in the reservoir krt that was consistent with sharp instrument damage, which most likely occurred during explant; hole was present, due to this damage being consistent with explant it will be considered a secondary failure.The ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested.No leaks were found.The pump was functionally tested and failed deflation test (3).The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 has a leak in proximal cylinder body attributed to sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Cylinder 1 was not functionally test due to leak was identified.Cylinder 2 was functionally tested and performed within specification; no leak was found.Product analysis concluded that identified pump failed deflation test could affect the functionality of the pump; therefore, product analysis confirmed device malfunction with the returned pump.The product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of caused traced to component failure was chosen, as product investigation identified device malfunction with the returned pump.The product analysis results and event report provided no objective evidence that would warrant further escalation.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis replaced due to fluid loss from the reservoir and the cylinders would not inflate.The reservoir had a visible hole resulting in fluid loss.Following the surgery, the patient was stable and well.The event resolved.

• 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: 10892420
• Report Number: 2183959-2020-05593
• Device Sequence Number: 3253938
• Product Code: FHW
• UDI-Device Identifier: 00878953003245
• UDI-Public: 00878953003245
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

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: 10/31/2021
• Device Model Number: 72404162
• Device Catalogue Number: 72404162
• Device Lot Number: 0153878002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/06/2020
• 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: 47 YR