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

Model Number 72404310

Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a revision surgery was performed, during which a crack in the connecting tube of the left cylinder was identified.The pump was removed and replaced.There were no patient complications reported.

Event Description

It was reported that the patient went to the hospital because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a revision surgery was performed, during which a crack in the connecting tube of the left cylinder was identified.The pump was removed and replaced.There were no patient complications reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The pump was visually and functionally inspected and tested for leaks.Visual inspection revealed that the tubing was cut down to the pump block; therefore, it was not returned for analysis.No leaks were identified in the pump; however, the component did not pass the activation test during functional evaluation.Based on the information available and analysis results, the pump not passing the functional examination could have caused or contributed to the reported clinical observation of mechanical issue.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18395496
• MDR Text Key: 331347915
• Report Number: 2124215-2023-73811
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/27/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2022
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0172148003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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
• Treatment: CYLINDERS: UPN: 72404273 / LOT: 164366003; CYLINDERS: UPN: 72404273 / LOT: 164366003; RESERVOIR: UPN: 720182-01 / LOT: 159394014; RESERVOIR: UPN: 720182-01 / LOT: 159394014
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male