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

Model Number 72404258

Device Problems Collapse (1099); Fluid/Blood Leak (1250); Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem Impotence (1925)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reservoir flat iz 100 ml.Device impotence mechanical/hydraulic.

Event Description

It was reported that patient liaison spoke with the patient regarding his inflatable penile prosthesis (ipp).He states that over the past few weeks when he pushes the deflate button in, it stays depressed.He also states that when he does pump his device he feels a squishing noise and does not get a full erection.Patient suspects that there is a leak within the system.Patient liaison did go over the reboot/reset maneuver with him to reset the valve if possible.He is going to try that and if he does not have success, he is going to make an appointment with the surgeon.Patient asked about warranty and patient liaison gave him the warranty process.He stated that in the past, the surgeon told him that if the device did not work for him that he would only replace the pump.Patient liaison did review with the patient that changing the entire device would be prudent and that it would be returned for analysis.He also stated that the surgeon suggested the two piece if he had trouble with the three piece.Patient liaison let him know that he could discuss with his doctor the possibility of having the three piece device reimplanted.

Manufacturer Narrative

Describe event or problem - updated.(b)(4).Reservoir flat iz 100 ml.Device impotence mechanical/hydraulic.

Event Description

It was reported that patient liaison spoke with the patient regarding his inflatable penile prosthesis (ipp).He states that over the past few weeks when he pushes the deflate button in, it stays depressed.He also states that when he does pump his device he feels a squishing noise and does not get a full erection.Patient suspects that there is a leak within the system.Patient experienced initial activation issues with pump at first follow up with physician.Patient liaison did go over the reboot/reset maneuver with him to reset the valve if possible.He is going to try that and if he does not have success, he is going to make an appointment with the surgeon.Patient asked about warranty and patient liaison gave him the warranty process.He stated that in the past, the surgeon told him that if the device didn't work for him that he would only replace the pump.Patient liaison did review with the patient that changing the entire device would be prudent and that it would be returned for analysis.He also stated that the surgeon suggested the two piece if he had trouble with the three piece.Patient liaison let him know that he could discuss with his doctor the possibility of having the three piece device reimplanted.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9145504
• MDR Text Key: 166400989
• Report Number: 2183959-2019-66450
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003665
• UDI-Public: 00878953003665
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: 03/27/2020
• Device Model Number: 72404258
• Device Catalogue Number: 72404258
• Device Lot Number: 1000080156
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/16/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR