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

Model Number 72404232-10

Device Problems Collapse (1099); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/23/2024

Event Type  Injury  

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 this inflatable penile prosthesis was unable to be inflated.The pump would stay dimpled after every squeeze.The device was explanted and replaced.No patient complications were reported.

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 this inflatable penile prosthesis was unable to be inflated.The pump would stay dimpled after every squeeze.The device was explanted and replaced.No patient complications were reported.

Event Description

It was reported that this inflatable penile prosthesis was unable to be inflated.The pump would stay dimpled after every squeeze.The device was explanted and replaced.No patient complications were reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Microscopic examination of the pump identified body fluid contamination.The pump passed leak testing but, due to the contamination, was not functionally tested.Microscopic examination of the first cylinder identified buckling folds in the proximal end, consistent with input tube wear.A hole, consistent with sharp instrument damage, was also identified.The cylinder did not pass leak testing.The second cylinder had buckling folds in the proximal end.It also had tool marks and a hole in the proximal end, consistent with sharp explant damage.The cylinder did not pass leak testing.The cylinder issues identified via analysis could have caused or contributed to the reported clinical observations.

• 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
• MDR Report Key: 18907483
• MDR Text Key: 337729007
• Report Number: 2124215-2024-15631
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009780
• UDI-Public: 00878953009780
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2021
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000292303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 113 KG