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

Model Number UNK-P-IPP

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problems Urinary Retention (2119); No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Implant date: the implant date of (b)(6) 2008 is an approximate date.Only the year is known.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery because the device failed to deflate.The existing ipp was explanted and replaced with an ambicor penile prosthesis (app).It is unknown if the explanted ipp is being returned.Should additional information be received, or product be returned, a supplemental report will be filed upon completion of the product analysis.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) revision surgery because the device failed to deflate.The existing ipp was explanted and replaced with an ambicor penile prosthesis (app).Additional information was later received from the physician clarifying that the device was remained approximately half inflated and could neither inflate further or deflate.Following the procedure a catheter was placed in the patient and removed the following day; however, the patient experienced urinary retention.The catheter was replaced and the patient discharged with a voiding trial to be performed on a later date.No further details have been received to date.It remains unknown if the explanted ipp will be returned.A supplemental report will be filed should further information become available or the product returned for analysis.

• 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: 8350179
• MDR Text Key: 136489019
• Report Number: 2183959-2019-60946
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR