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

Model Number	72404283
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related component, same system: model number: 720182-01, lot number: 1000078613, model description: reservoir flat 100 ml.
Event or Problem Description
It was reported that he inflatable penile prosthesis (ipp) device is going to be removed on a future date due to pain and infection.The patient "has been having continuous pain in the penis, especially on inflation.This has not settled despite antibiotics and analgesics, suggesting a chronic infection." after the device is removed if there are no signs of an active infection the physician plans to proceed with an immediate salvage and replacement with a new device.If there are signs of an active infection the physician plans to remove the device and then implant a new device a few weeks later.Additional information received states the patient did not have any other symptoms.He only reported "continuous pain, especially on inflation." the pain began immediately after implantation.The infection was located in the scrotum.The "patient had symptom of chronic infection which might have affected this implantation surgery." the physician does not believe that the device caused or contributed to the infection.The device still remains implanted and is planned to be removed.
Additional Manufacturer Narrative
Device evaluation: the ams700 ipp cylinders were visually inspected and functionally tested.There was a leak in the body of cylinder 1, which was consistent with sharp instrument damage.Based on the determination that the damage was likely due to explant, it will not be considered a probable cause for this event because it is a secondary failure.The ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested; no leaks were found.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.The allegation of infection could not be confirmed; however, a device malfunction was confirmed.The ams 700 conceal reservoir was visually inspected and functionally tested; no leaks were found.The reservoir therefore performed within specification.Related component, same system: model number: 720182-01.Lot number: 1000078613.Model description: reservoir flat 100 ml.
Event or Problem Description
It was reported that he inflatable penile prosthesis (ipp) device is going to be removed on a future date due to pain and infection.The patient "has been having continuous pain in the penis, especially on inflation.This has not settled despite antibiotics and analgesics, suggesting a chronic infection." after the device is removed if there are no signs of an active infection the physician plans to proceed with an immediate salvage and replacement with a new device.If there are signs of an active infection the physician plans to remove the device and then implant a new device a few weeks later.Additional information received states the patient did not have any other symptoms.He only reported "continuous pain, especially on inflation." the pain began immediately after implantation.The infection was located in the scrotum.The "patient had symptom of chronic infection which might have affected this implantation surgery." the physician does not believe that the device caused or contributed to the infection.The device still remains implanted and is planned to be removed.Additional information received states the explanted device was "defective.".

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9188704
• Report Number: 2183959-2019-66828
• Device Sequence Number: 2402371
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/29/2022
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 0181498007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR