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

Model Number 72404310

Device Problems 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 09/08/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced inflation issues with his inflatable penile prosthesis (ipp) and was unable to achieve an erection.A surgery was performed and air inside the pump was observed.The pump was removed and replaced.There were no patient complications.

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 Description

It was reported that the patient experienced inflation issues with his inflatable penile prosthesis (ipp) and was unable to achieve an erection.A surgery was performed and air inside the pump and a small hole in the reservoir was observed.The pump and reservoir were removed and replaced.There were no patient complications.

Manufacturer Narrative

Report 2124215-2022-39689 is a duplicate of this report.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The reservoir was visually and microscopically examined, and leak tested.Analysis identified a leak within the reservoir shell that was the result of wear at a fold.The pump was visually and microscopically examined, leak and functionally tested.No leaks were found; however, the pump did not pass the activation test.Based on the information available and analysis results, the reported reservoir hole and inflation issues were confirmed.The pump activation issue could have caused or contributed to the reported clinical observation of air in the system/component and inflation issues.

• Brand Name: AMS INFLATABLE 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15512628
• MDR Text Key: 300877453
• Report Number: 2124215-2022-38577
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2023
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000076761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 72 KG