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

Model Number 72404232

Device Problems Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 08/04/2020

Event Type  Injury  

Event Description

It was reported that the inflatable penile prosthesis (ipp) cylinders and pump were explanted due to fluid loss.The cylinders are flaccid and the pump collapsed.A new ipp device was implanted.Following the surgery the patient was fine.

Manufacturer Narrative

Correction provided in g1 -manufacture site facility name updated.The pump was not returned for analysis.The ams700 ipp cylinders were visually inspected and functionally tested.There was a large hole in the outer tube of both cylinders attributed to wear at fold in cylinder body.Cylinder 1 had a large leak and broken fabric threads in the cylinder body attributed to wear at fold.The kink resistant tubing (krt) of cylinder 1 was worn to the filament.Cylinder 2 had a pinhole leak in the cylinder body attribute to wear at fold.Both cylinders were not pressure test due to the leaks that were identified.Product analysis confirmed the reported events related to fluid leak and cylinder inflation issue but was unable to confirm the reported event related to the pump collapse.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found the device met all production specifications prior to shipment from boston scientific.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen.

Event Description

It was reported that the inflatable penile prosthesis (ipp) cylinders and pump were explanted due to fluid loss.The cylinders are flaccid and the pump collapsed.A new ipp device was implanted.Following the surgery the patient was fine.

• 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
• MDR Report Key: 10466812
• MDR Text Key: 204752454
• Report Number: 2183959-2020-03830
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003450
• UDI-Public: 00878953003450
• 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,o
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/24/2019
• Device Model Number: 72404232
• Device Catalogue Number: 72404232
• Device Lot Number: 0181838006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR