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

Model Number 72404310

Device Problems Collapse (1099); Mechanical Problem (1384)

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

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that due to a right connector disorder the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was also included that there was a "pump connection tube failure." additional information was received that the pump bulb stayed flat when pressing the bulb.This occurred two weeks ahead of surgery and the patient got well after this surgery.

Event Description

It was reported that due to a right connector disorder the patient had his inflatable penile prosthesis (ipp) pump removed and replaced.It was also included that there was a "pump connection tube failure." additional information was received that the pump bulb stayed flat when pressing the bulb.This occurred two weeks ahead of surgery and the patient got well after this surgery.

Manufacturer Narrative

A pump connection issue was reported along with pump collapse.The ams 700 momentary squeeze (ms) pump was visually inspected; no tubing nor connectors were present as the pump krt was cut down to the pump block.No leaks were identified.Pump contamination was present resulting in an inability to functionally test the pump.Product analysis was therefore unable to confirm the reported allegations.

• 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: 9624158
• MDR Text Key: 176241275
• Report Number: 2183959-2020-00224
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2021
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 127730005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 02/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR