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

Model Number	72401453
Medical Device Problem Codes	Deflation Problem (1149); Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the ambicor penile prosthesis (app) due to difficulties deflating the ipp.One cylinder was staying inflated at all times resulting in pain and discomfort, in the penis shaft, for the patient.Imaging was performed and a bulge was identified on the cylinder.A new ambicor penile prosthesis (app) was implanted.There were no additional patient complications reported.
Additional Manufacturer Narrative
Additional information provided to update d4 model number, catalog number, unique identifier, and d6a implant date.D6a implant date is approximate.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the ambicor penile prosthesis (app) due to difficulties deflating the device.One cylinder was staying inflated at all times resulting in pain and discomfort, in the penis shaft, for the patient.Imaging was performed and a bulge was identified on the cylinder.The entire app was replaced with a new app.There were no additional patient complications reported.
Additional Manufacturer Narrative
Updated information to h6 conclusion codes and additional mfr.Narrative.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the ambicor penile prosthesis (app) due to difficulties deflating the device.One cylinder was staying inflated at all times resulting in pain and discomfort, in the penis shaft, for the patient.Imaging was performed and a bulge was identified on the cylinder.The entire app was replaced with a new app.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the ambicor penile prosthesis (app) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual inspection of the cylinders identified that one of the cylinders presented a bulge and wear at a fold in the middle of the cylinder.This cylinder also had a hole that was consistent with sharp instrument damage.The other cylinder and pump did not show any signs of visual abnormalities and both components passed the leak testing.Based on the information available, the reported observation was confirmed, and a conclusion of cause traced to component failure was chosen.
Event or Problem Description
It was reported that this ambicor penile prosthesis (app) exhibited deflation difficulties.One cylinder remained inflated at all times resulting in pain and discomfort in the penis shaft for the patient.Imaging was performed and a bulge was identified on the cylinder.The entire app was replaced with a new app.There were no additional patient complications reported.

• Brand Name: AMS AMBICOR 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18121684
• Report Number: 2124215-2023-63665
• Device Sequence Number: 15338748
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: 00878953000978
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 02/28/2024

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 Model Number: 72401453
• Device Catalogue Number: 72401453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 12/06/2023; 02/12/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 11/29/2023; 12/11/2023; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male