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

Model Number	72404230
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis revised due to a sticky pump.
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 was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.However, product analysis concluded that identified a pump failed activation test was the most probable cause of the device malfunction.Product analysis confirmed pump malfunction.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis revision due to a sticky pump.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11163245
• Report Number: 2183959-2021-00027
• Device Sequence Number: 677064
• Product Code: FHW
• UDI-Device Identifier: 00878953003436
• UDI-Public: 00878953003436
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 10/18/2020
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 1000179988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/10/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 86562
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR