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

Model Number 72404252-10

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504); Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 09/05/2023

Event Type  Injury  

Event Description

It was reported that during an inflatable penile prosthesis (ipp) implant surgery, the physician accidentally had a corporotomy crossover during dilation.The physician perforated the device while adding a suture to the corporotomy.Therefore, another ipp cylinders were implanted.There were no further patient complications.

Event Description

It was reported that during an inflatable penile prosthesis (ipp) implant surgery, the physician accidentally had a corporotomy crossover during dilation.The physician perforated the device while adding a suture to the corporotomy.Therefore, another ipp cylinders were implanted.There were no further patient complications.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The conclusion was selected because the reason for difficult to insert, use of device issue - user error, hole/perforated, perforation were determined to be inadvertent/unintentional interaction.Furthermore, according with the information in the event description, the device was on good condition when the package was open.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, it can be concluded that inadvertent/unintentional interaction was the most probable cause of the complaint/event.This investigation was assigned a most probable conclusion code of unintended use error caused or contributed to event.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17783383
• MDR Text Key: 323862944
• Report Number: 2124215-2023-51481
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Race: White