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

Model Number 72404238

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907)

Event Date 02/19/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a cardiac arrest during the implantation of an inflatable penile prosthesis (ipp).The patient coded half way through the procedure.Only the reservoir component had been implanted at this point.The surgeon immediately explanted the reservoir and began chest compressions until the patient's pulse was resorted.The patient was transferred to (b)(6) medical center after they were stabilized.The head of the hospital's anesthesiology department who was called into the operating room at the time of the incident, reported that the patient may have experienced an adverse drug reaction to the administered vancomycin.The incident was not attributed to the ipp device.The patient was seen by another urologist in the days that followed the event.This urologist reported that the patient had recovered from the incident and that they were doing well.A future ipp procedure has not been scheduled for the patient.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: mike bocchino ; 10700 bren road w; minnetonka, MN 55343 ; 6515827161
• MDR Report Key: 8438403
• MDR Text Key: 139409490
• Report Number: 2183959-2019-61665
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003511
• UDI-Public: 00878953003511
• Combination Product (y/n): N
• 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
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2020
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000160293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention