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

Model Number 72404252-10

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)

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

Event Date 02/03/2023

Event Type  Injury  

Event Description

It was reported that the patient was having difficulties deflating his inflatable penile prosthesis (ipp).The ipp was explanted and replaced with an ambicor penile prosthesis.There were no patient complications.

Manufacturer Narrative

Upon receipt of this implantable penile prosthesis (ipp) at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis of the returned ams 700 momentary squeeze (ms) pump did not detect any abnormality, and no leaks were found.During the functional testing, the ms pump did not pass the activation test.The ams700 ipp cylinders were visually inspected and functionally tested, and no leaks were found.A review of the device history record confirmed that the device met manufacturing specification prior to release.Based on the analysis results of the device, the reported event is confirmed.The observed deflation difficulty was most likely the result of the pump anomaly identified during product analysis.

Event Description

It was reported that the patient was having difficulties deflating his inflatable penile prosthesis (ipp).The ipp was explanted and replaced with an ambicor penile prosthesis.There were no patient complications.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16446284
• MDR Text Key: 310282287
• Report Number: 2124215-2023-08638
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009810
• UDI-Public: 00878953009810
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2022
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1000389006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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: RESERVOIR LOT: 1000414676 UPN: 720185-01; RESERVOIR LOT: 1000414676 UPN: 720185-01
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male