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

Model Number 72403356

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 has leaks in the cylinder body attributed to wear at fold; holes were present.Both cylinders had leak in the rear tip proximal cylinder that was the result of sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Both cylinders had wear at fold in cylinder body.Both cylinders were not pressure test due to leak was identified.The ipp cxm inflate/deflate pump was visually inspected; no leaks were found.The outer layer of pump bulb was worn that result of wear against the pump strain relief krt junction; no leaks were found.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The identified fluid leak is also the probable cause of the reported mechanical issue, as the device would not be functional after the system fluid was lost.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 because the reported events could be traced to a component failure.

Event Description

It was reported that the patient had a surgical procedure to replace the inflatable penile prosthesis(ipp) due to the device not working.The surgeon believed that the product was aging and replaced the device.No patient clinical consequences were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11240749
• MDR Text Key: 229084989
• Report Number: 2183959-2021-00182
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2007
• Device Model Number: 72403356
• Device Catalogue Number: 72403356
• Device Lot Number: 361468010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR