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

Model Number 72404310

Device Problems Failure to Cycle (1142); Connection Problem (2900)

Patient Problem Discomfort (2330)

Event Date 07/27/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a pump connector disorder with an inflatable penile prosthesis (ipp).The ipp pump, cylinder, and reservoir was explanted and a new ipp pump, cylinder and reservoir was implanted.Additional information was reported that the connector had been worn down, and the patient had difficulties cycling the device.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Event Description

It was reported that the patient experienced a pump connector disorder with an inflatable penile prosthesis (ipp).The ipp pump, cylinder, and reservoir was explanted and a new ipp pump, cylinder and reservoir was implanted.Additional information was reported that the connector had been worn down, and the patient had difficulties cycling the device.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Manufacturer Narrative

Device analysis: connector disorder was reported.No connectors were received.The ams700 momentary squeeze pump was visually inspected.No leak was found.The pump was not functionally tested due to contamination.The allegation of connector disorder could not be confirmed as no connectors were returned.No device malfunction was confirmed for the pump component.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.

• 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: 8915176
• MDR Text Key: 155031022
• Report Number: 2183959-2019-65758
• 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: 10/21/2019

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: 02/06/2021
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 120127004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR