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

Model Number UNK-P-IPP

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, used the first date in the aware month.Investigation summary: based on the information available, the cause that contributed to the reported bleeding, extrusion, and device migration could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) of the manufacturing documentation was not performed as the serial/lot number for this component was not provided.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of bleeding, extrusion , and device migration cannot be confirmed.Labeling review: a labeling review was performed and according to the ipp instruction for use document, extrusion is documented as an adverse event.Also there is no evidence that the device was used or handled improperly.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of known inherent risk of device has been chosen.

Event Description

It was reported that the patient had the inflatable penile prosthesis removed due to bleeding and a piece of wire popped out at 4 1/2 weeks post implant.The patient went to the er to have it removed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 11740394
• MDR Text Key: 247913260
• Report Number: 2124215-2021-10755
• 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
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR