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

Model Number 72404238

Device Problems Break (1069); Failure to Cycle (1142); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  Injury  

Event Description

It was reported that the inflatable penile prosthesis (ipp) would not cycle and pump up.Both cylinders were ruptured and would not hold fluid.The device was removed and replaced with a new ipp.The patient had a good outcome with no further complications.

Event Description

It was reported that the inflatable penile prosthesis (ipp) would not cycle and pump up.Both cylinders were ruptured and would not hold fluid.The device was removed and replaced with a new ipp.The patient had a good outcome with no further complications.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.The ams 700 momentary squeeze (ms) pump was visually inspected.The pump krt was worn to filament; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The ams 700 flat reservoir was visually inspected and functionally tested.The reservoir shell has wear at fold; no leak was found.The ams700 ipp cylinders were visually inspected and functionally tested.Both cylinders had a leak in cylinder body.Both cylinders had broken fabric threads and a tear/break in the outer tube due to input tube wear with avulsion.Both cylinders had wear at fold in cylinder body.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 for tcf 769689 found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.There is no evidence that the reported events are related to a manufacturing deficiency based on the product analysis and a review of the manufacturing records.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

• 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: 10390132
• MDR Text Key: 202350217
• Report Number: 2183959-2020-03459
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2014
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 769689003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 08/24/2020
• Patient Sequence Number: 1
• Treatment: 720185-01/798212017
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR