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

Model Number UNK-P-IPP

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 07/14/2023

Event Type  Injury  

Event Description

It was reported that the pump of this inflatable penile prosthesis (ipp) is located higher in the pelvis, rather than in the scrotum, causing the patient pain.It is also causing difficulty with inflating and deflating the device.At an in-clinic follow up, the physician attempted to pull the pump down without improvement.The patient also expressed dissatisfaction with the post-operative length and girth of their penis and is considering replacing their device as a result.No further patient complications were reported.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.The evidence from the product record review did not identify a potential product quality issue or new patient harm.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, conclusion codes of known inherent risk of device and inadvertent or unintentional interaction were assigned to this investigation.

Event Description

It was reported that the pump of this inflatable penile prosthesis (ipp) is located higher in the pelvis, rather than in the scrotum, causing the patient pain.It is also causing difficulty inflating and deflating the device.At an in-clinic follow up, the physician attempted to pull the pump down without improvement.The patient also expressed dissatisfaction with the post-operative length and girth of their penis and is considering replacing their device as a result.No further patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18107589
• MDR Text Key: 327865292
• Report Number: 2124215-2023-63145
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• 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: 56 YR