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

Model Number 72404253-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 07/06/2022

Event Type  Injury  

Event Description

It was reported that during an inflatable penile prosthesis (ipp) implant procedure, there was some kind of trauma caused to the iliac artery and vein when the physician attempted to perform blunt dissection to allow space for the reservoir.A general surgeon and a vascular surgeon had to be called to stop the bleeding.It was indicated that the blood loss was substantial; however, the vascular and general surgeon were able to stabilize the patient.Due to the trauma experienced, the procedure was stopped before the device could be implanted.The patient had been administered anesthesia prior to the procedure cancellation.There were no further patient complications.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation during the procedure.Vessel trauma and hemorrhage are known risks associated with implants of these devices as indicated in the product labeling and risk documentation.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that during the implant of this inflatable penile prosthesis (ipp), the iliac artery and vein were injured when the physician attempted blunt dissection to allow space for the reservoir.It was noted that substantial bleeding occurred; the bleeding was stopped following intervention by a surgeon and vascular surgeon.The patient was then stabilized and the procedure was called off.There were no further patient complications reported.

• 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: 15093306
• MDR Text Key: 296474361
• Report Number: 2124215-2022-27128
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009827
• UDI-Public: 00878953009827
• 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
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1000522956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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): Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Male