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

Model Number 72401452

Device Problems Inflation Problem (1310); Failure to Deflate (4060)

Patient Problem Discomfort (2330)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that the patient with an ambicor penile prosthesis (app) contacted patient services regarding the level to which the device could be expected to deflate.It was explained that due to the nature of the two-piece device, it may not deflate and conceal as completely as a three-piece device.The patient was provided with educational materials and advised to reach out again after consulting with their physician for pump training if necessary.Several months later, the patient called reporting inability deflating the device enough to be comfortable.The patient reported a constant erection that prohibits them from doing various activities.The patient also noted they are able to have intercourse without pumping up the device.When the patient does attempt to pump the device, the result of the erection does not change.The patient followed up with their provider but was advised to continue using and learning the device.The patient was again referred to their physician for additional follow up to rule out any device issues.There has been no surgical intervention at this time and no additional patient complications were reported.

Event Description

It was reported that the patient with an ambicor penile prosthesis (app) contacted patient services regarding the level to which the device could be expected to deflate.It was explained that due to the nature of the two-piece device, it may not deflate and conceal as completely as a three-piece device.The patient was provided with educational materials and advised to reach out again after consulting with their physician for pump training if necessary.Several months later, the patient called reporting inability to deflate the device enough to be comfortable.The patient reported a constant erection that prohibits them from doing various activities.The patient also noted they are able to have intercourse without pumping up the device.When the patient does attempt to pump the device, the degree of erection does not change.The patient followed up with their provider but was advised to continue using and learning the device.The patient was again referred to their physician for additional follow up to rule out any device issues.At a later date, the patient underwent surgical intervention to explant the app and implant an inflatable penile prosthesis (ipp).There were no additional patient complications reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of discomfort is 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 Description

It was reported that the patient with an ambicor penile prosthesis (app) contacted patient services regarding the level to which the device could be expected to deflate.It was explained that due to the nature of the two-piece device, it may not deflate and conceal as completely as a three-piece device.The patient was provided with educational materials and advised to reach out again after consulting with their physician for pump training if necessary.Several months later, the patient called reporting inability to deflate the device enough to be comfortable.The patient reported a constant erection that prohibits them from doing various activities.The patient also noted they are able to have intercourse without pumping up the device.When the patient does attempt to pump the device, the degree of erection does not change.The patient followed up with their provider but was advised to continue using and learning the device.The patient was again referred to their physician for additional follow up to rule out any device issues.There has been no surgical intervention at this time and no additional patient complications were reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of discomfort is 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.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Type of Device: 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: 18359513
• MDR Text Key: 330910628
• Report Number: 2124215-2023-72249
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953000961
• UDI-Public: 00878953000961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 1000386002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male