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

Model Number 72404238

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Material Puncture/Hole (1504); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that the patient heard a "pop" during sex and the inflatable penile prosthesis (ipp) did not work afterwards.A replacement surgery was performed and there were no further complications.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Manufacturer Narrative

Information corrected: implant date the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that the patient heard a "pop" during sex and the inflatable penile prosthesis (ipp) did not work afterwards.A replacement surgery was performed and there were no further complications.

Manufacturer Narrative

Additional information: after dr inspection, a hole was found on the device.Information corrected: implant date the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that the patient heard a "pop" during sex and the inflatable penile prosthesis (ipp) did not work afterwards and could not be inflated at all.A replacement surgery was performed in which air was observed inside the device and the physician noticed a hole in the device therefore a fluid leak is suspected.All components were removed and replace.No patient complications were reported.

Event Description

It was reported that the patient heard a pop during sex and the inflatable penile prosthesis (ipp) did not work afterwards and could not be inflated at all.A replacement surgery was performed in which air was observed inside the device and the physician noticed a hole in the device therefore a fluid leak is suspected.All components were removed and replace.No patient complications were reported.

Manufacturer Narrative

Information corrected: aware date the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14210608
• MDR Text Key: 290089350
• Report Number: 2124215-2022-13148
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003511
• UDI-Public: 00878953003511
• Combination Product (y/n): Y
• 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
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2021
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000323285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• 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: UPN 72404155/ LOT 1000355207; RESERVOIR: UPN 72404155/ LOT 1000355207; RESERVOIR: UPN 72404155/ LOT 1000355207; RESERVOIR: UPN 72404155/ LOT 1000355207
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male