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

Model Number 72401455

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Urinary Retention (2119)

Event Date 07/03/2020

Event Type  Injury  

Event Description

It was reported that an ambicor penile prosthesis (app) device was explanted due the distal part of the cylinders eroded.The patient does not want to consider a re-implant surgery at this time.The patient's presenting symptoms that led to the erosion discovery were difficulties with urinary retention that included pain in the urinary meatus and bleeding.The patient experienced these symptoms while still in the hospital from the original surgery while under observation.The patient had a foley catheter placed and removed during the original surgery, but after the patient started experiencing these symptoms a french foley catheter was placed to help with the urinary retention.At this time, the urethral erosion and the right cylinder's tip of the device was also visible.The physician believes the device contributed to these issues as there was too much pressure inside the corpora which resulted in a distal crossover.The patient is now stable and has not received a re-implant of his device.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• 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: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10405358
• MDR Text Key: 202854175
• Report Number: 2183959-2020-03513
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: 00878953000992
• Combination Product (y/n): N
• Reporter Country Code: RQ
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• Device Lot Number: 1000343832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR