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

Model Number	72404281
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is experiencing issues with an inflatable penile prosthesis(ipp) pump.The pump doesn't work and the patient is having problems squeezing the pump but the cylinders not inflating.A revision will take place once a replacement pump is delivered to the customer.A patient outcome of stable was reported.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported fluid loss cannot be established as the product is not available for analysis.Device history record (dhr) : the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis : the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient experienced issues with an inflatable penile prosthesis(ipp) pump.The pump didn't work and the patient was having problems squeezing the pump but the cylinders not inflating.A revision surgery occurred to replace the pump and fluid loss was found.A patient outcome of stable was reported.

• 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: 10751799
• Report Number: 2183959-2020-05180
• Device Sequence Number: 11047642
• Product Code: FHW
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• 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: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 08/13/2018
• Device Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 842472001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 02/20/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention