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

Model Number 72404310

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Model number: 72404012, lot number: 1000282662, model description: cxr 14cm.Model number: 72404161, lot number: 1000314609, model description: reservoir 65ml pc.

Event Description

It was reported that the inflatable penile prosthesis (ipp) device was originally implanted on (b)(6) 2016.The patient then visited the hospital because he was not able to operate his device since (b)(6).In (b)(6) 2020 the doctor was able to confirm that there was a problem with operating the pump and decided to perform a revision surgery.The pump would dimple and would not return to it's original shape.During the surgery, after the pump was exposed it was tested again.The pump continued to dimple repeatedly even when "not operated according to the manual." during the surgery it was also confirmed "that there were problems with the pumps, cylinders and reservoir." all solution was removed from the reservoir and it was found there was no solution.The reservoir was filled with solution again and removed a few minutes later.It was found there was a little difference in the amount of fluid that was removed.A hole was identified in the cylinder when the "doctor checked each cylinder from out of the patient penis." it is not known when the device perforation occurred, but it is not believed to be caused by a device malfunction.After confirming that there a new device was available, the doctor removed the entire ipp device, re-measured the length of the cylinders, and implanted a new ipp device.After implanting the new device it was confirmed that there was no abnormality with the device.There were no further problems following the surgery.

Manufacturer Narrative

Correction information provided in: b5.Device evaluation provided in: d10, h3 and h6.Device evaluation: the ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and failed activation test.Product analysis confirmed the reported events.The ams700 ipp cylinder was visually inspected and functionally tested.There was a leak in a cylinder body that result of a sharp instrument damage; hole was identified in cylinder body.The hole was consistent with explant damage and was considered a secondary failure product analysis could not confirm the reported events.The ams 700 spherical reservoir was visually inspected and functionally tested; no leaks were found.The reservoir therefore performed within specification.Product analysis was unable to confirm the reported events.D4: model number: 72404012 lot number: 1000282662 model description: cxr 14cm model number: 72404161; lot number: 1000314609; model description: reservoir 65ml pc.

Event Description

It was reported that the inflatable penile prosthesis (ipp) device was originally implanted on (b)(6) 2020.The patient then visited the hospital because he was not able to operate his device since march.In (b)(6) 2020 the doctor was able to confirm that there was a problem with operating the pump and decided to perform a revision surgery.The pump would dimple and would not return to it's original shape.During the surgery, after the pump was exposed it was tested again.The pump continued to dimple repeatedly even when "not operated according to the manual." during the surgery it was also confirmed "that there were problems with the pumps, cylinders and reservoir." all solution was removed from the reservoir and it was found there was no solution.The reservoir was filled with solution again and removed a few minutes later.It was found there was a little difference in the amount of fluid that was removed.A hole was identified in the cylinder when the "doctor checked each cylinder from out of the patient penis." it is not known when the device perforation occurred, but it is not believed to be caused by a device malfunction.After confirming that there a new device was available, the doctor removed the entire ipp device, re-measured the length of the cylinders, and implanted a new ipp device.After implanting the new device it was confirmed that there was no abnormality with the device.There were no further problems following the surgery.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10079070
• MDR Text Key: 193032466
• Report Number: 2183959-2020-02302
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2024
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000307822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 07/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR