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

Model Number	72404283
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient experienced inflation issues with this inflatable penile prosthesis (ipp).A magnetic resonance imaging (mri) scan was performed that indicated that the reservoir was empty.A replacement surgery was recommended; however, it had not been performed.There were no patient complications reported.
Additional Manufacturer Narrative
The complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Due to the lack of product return, the clinical observations of inflation issues and fluid loss could not be confirmed.
Event or Problem Description
It was reported that the patient experienced inflation issues with this inflatable penile prosthesis (ipp).A magnetic resonance imaging (mri) scan was performed which indicated that the reservoir was empty.A replacement surgery was performed five months later.There were no patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13446507
• Report Number: 2124215-2022-03231
• Device Sequence Number: 4321696
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 10/16/2019
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 902744005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male