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

Model Number 72404231

Device Problems Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  Injury  

Event Description

It was reported that the inflatable penile prosthesis (ipp) device is going to be revised on the first week in december because the "cylinders do not fill with liquid." additional information received states the pump bulb stayed flat and air was observed in the device.There was no hole observed in the device.It is believed there was fluid loss from the pump but the cause or source of the fluid loss was not known.It was observed that the pump was not pumping and was malfunctioning.The device issues began approximately 4 months prior to the surgery.Only the ipp cylinders were replaced.

Manufacturer Narrative

Device analysis: allegations related to inflation issues and pump malfunction were reported.The ams700 ipp cylinders and ms pump were visually inspected.One of the cylinders was separated in two pieces; a damage which was concluded to be sharp instrument damage consistent with explant damage.It was therefore considered a secondary failure.The other cylinder performed within specification.The pump was unable to be functionally tested due to contamination.Product analysis was unable to confirm the reported events.Visual inspection of the ams 700 ipp cylinders and momentary squeeze (ms) pump was unable to confirm the reported allegations of pump malfunction and inflation issues.The pump was unable to be functionally tested due to contamination and one of the cylinders could not be functionally tested.The other cylinder performed within specification.The product record review confirmed the reported events do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of cause not established was chosen as the most probable cause, because the cause of the reported events could not be identified through product investigation.The product analysis results and event report provided no objective evidence that would warrant further escalation.

Event Description

It was reported that the inflatable penile prosthesis (ipp) device is going to be revised on the first week in december because the cylinders do not fill with liquid additional information received states the pump bulb stayed flat and air was observed in the device.There was no hole observed in the device.It is believed there was fluid loss from the pump but the cause or source of the fluid loss was not known.It was observed that the pump was not pumping and was malfunctioning.The device issues began approximately 4 months prior to the surgery.Only the ipp cylinders were replaced.

• 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: 9498056
• MDR Text Key: 175710488
• Report Number: 2183959-2019-68271
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003443
• UDI-Public: 00878953003443
• 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: 03/30/2020

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: 11/04/2012
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 682169005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR