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

Model Number	72404303
Medical Device Problem Codes	Failure to Cycle (1142); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that due to the cylinders not filling even after displacing/compressing the pump; the medium could not be drawn into the pump following the pump impacts.The patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of cylinders, pump, and reservoir were implanted.It was reported that there were no patient complications associated with this surgery.Further information indicated that this was an attempted pump implant, but the pump needed to be replaced due to after moving/compressing the pump, the cylinders were not filing.A different pump was used to achieve the desired results.
Event or Problem Description
It was reported that due to the cylinders not filling even after displacing/compressing the pump; the medium could not be drawn into the pump following the pump impacts.The patient had his inflatable penile prosthesis (ipp) removed and replaced.The ipp was explanted and a new device consisting of cylinders, pump, and reservoir were implanted.It was reported that there were no patient complications associated with this surgery.Further information indicated that this was an attempted pump implant, but the pump needed to be replaced due to after moving/compressing the pump, the cylinders were not filing.A different pump was used to achieve the desired results.
Additional Manufacturer Narrative
An allegation of "failure to cycle" was reported.The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and multiple functional test failures were identified.These functional test failures would directly affect the functionality of the device and therefore confirm the failure to cycle allegation.

• 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: 9673450
• Report Number: 2183959-2020-00470
• Device Sequence Number: 2923479
• Product Code: FHW
• UDI-Device Identifier: 00878953005744
• UDI-Public: 00878953005744
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/28/2020

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: 06/17/2024
• Device Model Number: 72404303
• Device Catalogue Number: 72404303
• Device Lot Number: 1000289583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR