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

Model Number 72404281

Device Problems Collapse (1099); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 06/11/2020

Event Type  Injury  

Event Description

It was reported that the patient had a pump replacement surgery due to a dimpled pump with his inflatable penile prosthesis (ipp).

Manufacturer Narrative

Correction to h2, h3, and h6: updated to include device analysis.Product analysis summary product analysis confirmed the reported event related to pump collapse and mechanical issue.The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The pump was functionally tested and failed activation test.Product analysis concluded that identified a pump failed activation test was the most probable cause of the device malfunction.Dhr review / similar complaint 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 batch 1000002554 and it respective container 21289053, 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.Additionally, potential emerging trends are captured as part of the post market signal evaluation and escalation process.Risk review the ams 700 hazard analysis indicates that the as reported events of this complaint do not represent a new hazardous situation.Additionally, boston scientific does not have responsibility to provide training to medical professional as documented in the dfu/ifu, and the ams 700 is not a new product because it is not within the first six months of its release in any geography, and it is not a new design platform.No further review is required.

Event Description

It was reported that the patient had a pump replacement surgery due to a dimpled pump with his inflatable penile prosthesis (ipp).It was added that the pump did not work and was "freezing" when trying to use it.The patient was experiencing these problems with the pump and also pain prompting him to see his physician.The onset of these issues was (b)(6)2020.The patient outcome following this surgery was "not bad.".

• 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: 10236434
• MDR Text Key: 197679042
• Report Number: 2183959-2020-02814
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• 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: 07/22/2020

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: 11/30/2022
• Device Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1000002554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/19/2020
• Supplement Dates FDA Received: 07/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR