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

Model Number 72404310

Device Problem Collapse (1099)

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

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and failed the activation test.Product analysis therefore confirmed a pump malfunction.

Event Description

It was reported the patient had the inflatable penile prosthesis pump component removed due to dimpled pump.A new inflatable penile prosthesis pump component was implanted.Additional information received indicated it stayed flat when pressing the bulb.The patient outcome was that he got well.

• 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: 9947471
• MDR Text Key: 187174274
• Report Number: 2183959-2020-01975
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• 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: 04/09/2020

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: 10/17/2023
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000178282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR