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

Model Number 72404236

Device Problems Failure to Cycle (1142); Inflation Problem (1310); Defective Device (2588); Air/Gas in Device (4062)

Patient Problems Pain (1994); Scar Tissue (2060); No Consequences Or Impact To Patient (2199); Discomfort (2330); Swelling/ Edema (4577)

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that the patient had an inflatable penile prosthesis (ipp) implanted in (b)(6) 2020 but was never able to inflate the device.The patient met up with the physician to troubleshoot the ipp.It was observed that the patient had a "sticky pump" that was very hard to compress, did not push liquid into the cylinders and was slow to fill.During the appointment they were able to manually reset the valve by rapidly alternating inflate and deflate squeezes.The patient was trained on how to troubleshoot the pump.No more information had been received through the patient leading to believe that the device was working after the appointment.There were no patient complications related to the device.

Event Description

It was reported that the patient had an inflatable penile prosthesis (ipp) implanted in (b)(6) 2020 but was never able to inflate the device.The patient met up with the physician to troubleshoot the ipp.It was observed that the patient had a "sticky pump" that was very hard to compress, did not push liquid into the cylinders and was slow to fill.During the appointment they were able to manually reset the valve by rapidly alternating inflate and deflate squeezes.The patient was trained on how to troubleshoot the pump.The patient was unable to consistently get the pump to work a month after the appointment causing the patient to be frustrated.The patient indicated maybe swapping the device in the future.There were no patient complications related to the device.

Manufacturer Narrative

B5, h2, h6, h10 updated.

Event Description

It was reported that the patient had an inflatable penile prosthesis (ipp) implanted in (b)(6) 2020 but was never able to inflate the device.The patient met up with the physician to troubleshoot the ipp as initial activation issues were encountered on first follow up.It was observed that the patient had a "sticky pump" that was very hard to compress, did not push liquid into the cylinders and was slow to fill.During the appointment they were able to manually reset the valve by rapidly alternating inflate and deflate squeezes.The patient was trained on how to troubleshoot the pump.The patient was unable to consistently get the pump to work a month after the appointment causing the patient to be frustrated.The patient indicated maybe swapping the device in the future.There were no patient complications related to the device.

Manufacturer Narrative

There was no device available for analysis.The reported patient symptoms are known risks associated with implant of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 had an inflatable penile prosthesis (ipp) implanted in (b)(6) 2020 but was never able to inflate the device.The patient experienced penile and scrotal pain as well as moderate swelling, scrotal discomfort, and tenderness to the touch.Four months after implant, the patient had a follow up to get the ipp activated, as the original appointment had to be pushed back several times.During activation, a small airlock was identified, and the patient had a "sticky pump" that was very hard to compress, did not push liquid into the cylinders and was slow to fill.; however, the physician was able to release the airlock and reset the valve by rapidly alternating inflate and deflate squeezes.It was noted that the doctor suspected the pump stiffness was due to not cycling for multiple months since implant, additionally it was suspected that the scrotal discomfort could be related to scar tissue and lack of pump manipulation.Following initial activation, the patient had several follow up appointments as he found the device difficult to inflate.The physician and sales representative were able to manipulate the ipp appropriately; therefore, the patient was provided with additional device training sessions.After three months, the patient was still unable to consistently cycle the device on his own, causing him to be frustrated.The valve appeared to be sticking; however, the pump could be manipulated to release the valve.It was noted that when properly inflated, the device seated appropriately.The patient indicated maybe swapping the device in the future.There were no further patient complications related to the device.

Manufacturer Narrative

There was no device available for analysis.The reported patient symptoms are known risks associated with implant of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 had an inflatable penile prosthesis (ipp) implanted in (b)(6) 2020 but was never able to inflate the device.The patient experienced penile and scrotal pain as well as moderate swelling, scrotal discomfort, and tenderness to the touch.Four months after implant, the patient had a follow up to get the ipp activated, as the original appointment had to be pushed back several times.During activation, a small airlock was identified, and the patient had a "sticky pump" that was very hard to compress, did not push liquid into the cylinders and was slow to fill.; however, the physician was able to release the airlock and reset the valve by rapidly alternating inflate and deflate squeezes.It was noted that the doctor suspected the pump stiffness was due to not cycling for multiple months since implant, additionally it was suspected that the scrotal discomfort could be related to scar tissue and lack of pump manipulation.Following initial activation, the patient had several follow up appointments as he found the device difficult to inflate.The physician and sales representative were able to manipulate the ipp appropriately; therefore, the patient was provided with additional device training sessions.After three months, the patient was still unable to consistently cycle the device on his own, causing him to be frustrated.The valve appeared to be sticking; however, the pump could be manipulated to release the valve.It was noted that when properly inflated, the device seated appropriately.The patient indicated not wanting to undergo a surgical procedure to address the device experience.There were no further patient complications related to the device.

Event Description

It was reported that the patient had an inflatable penile prosthesis (ipp) implanted in (b)(6) 2020 but was never able to inflate the device.The patient experienced penile and scrotal pain as well as moderate swelling, scrotal discomfort, and tenderness to the touch.Four months after implant, the patient had a follow up to get the ipp activated, as the original appointment had to be pushed back several times.During activation, a small airlock was identified, and the patient had a "sticky pump" that was very hard to compress, did not push liquid into the cylinders and was slow to fill.; however, the physician was able to release the airlock and reset the valve by rapidly alternating inflate and deflate squeezes.It was noted that the doctor suspected the pump stiffness was due to not cycling for multiple months since implant, additionally it was suspected that the scrotal discomfort could be related to scar tissue and lack of pump manipulation.Following initial activation, the patient had several follow up appointments as he found the device difficult to inflate.The physician and sales representative were able to manipulate the ipp appropriately; therefore, the patient was provided with additional device training sessions.After three months, the patient was still unable to consistently cycle the device on his own, causing him to be frustrated.The valve appeared to be sticking; however, the pump could be manipulated to release the valve.It was noted that when properly inflated, the device seated appropriately.The patient indicated not wanting to undergo a surgical procedure to address the device experience.There were no further patient complications related to the device.

Manufacturer Narrative

There was no device available for analysis.The reported patient symptoms are known risks associated with implant of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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 ; 4089353452
• MDR Report Key: 10197894
• MDR Text Key: 197336269
• Report Number: 2183959-2020-02705
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003498
• UDI-Public: 00878953003498
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2021
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1000319363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0427-2021
• Patient Sequence Number: 1
• Treatment: RESERVOIR 65 ML PC/IZ 72404155/1000317440
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male