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

Model Number 72404232-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported hematoma, edema, blood loss, and infection could not be established as the product was not available for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported allegation of infection cannot be confirmed.Labeling review: a review of the device instructions for use (ifu) was completed and according to the ams700 instructions for use, hematoma, edema, blood loss, and infection are documented as adverse events.Investigation conclusion: based on this investigation a clear probable cause for the event cannot be established.Risk review and labeling review identified that the adverse events of hematoma, edema, infection and blood loss are known risks of the device.The cause of the hematoma, edema, infection and blood loss were not established by physician, although hematoma, edema, infection and blood loss are included in the labelling documentation for ipp device as an adverse event of implant surgical procedure of device and also the risks, benefits, and potential adverse events of all available treatment options should be discussed with the patient and considered by the physician and patient when choosing a treatment option is included in the document, therefore a conclusion code of known inherent risk of device was chosen.

Event Description

It was reported that the patient had the inflatable penile prosthesis remove due to a large hematoma in scrotal area as well as scrotal edema and bleeding.The physician felt that the patient may have started to exercise or walk one week after surgery but unsure if this is what caused the hematoma.The device was removed for precaution for a possible infection and the wound was irrigated with antibiotics.The procedure completed successfully.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12205388
• MDR Text Key: 262739754
• Report Number: 2124215-2021-20569
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009780
• UDI-Public: 00878953009780
• 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
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/05/2022
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000466831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR