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

Model Number 72404012

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 11/28/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to pain as a result of the cylinders and rear tip extenders (rte) being too long with an inflatable penile prosthesis (ipp).The ipp remains implanted and active and the 1.5cm rte was explanted and a new 0.5cm rte was implanted.The patient was stable following the procedure and the patient's symptoms improved.

Manufacturer Narrative

Device evaluated by mfr: the ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders were pressure tested and performed within specification.

Event Description

It was reported that the patient underwent a revision procedure due to pain as a result of the cylinders and rear tip extenders (rte) being too long with an inflatable penile prosthesis (ipp).The ipp remains implanted and active and the 1.5cm rte was explanted and a new 0.5cm rte was implanted.The patient was stable following the procedure and the patient's symptoms improved.

• 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: 11023070
• MDR Text Key: 221866507
• Report Number: 2183959-2020-05958
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953002699
• UDI-Public: 00878953002699
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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: 02/14/2024
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1000230266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR