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

Model Number 72404233-12

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 07/04/2021

Event Type  Injury  

Event Description

It was reported that the patient was cleared to use his device on approximately july 3 and had successful intercourse with his wife that night.He states that she noted that his scrotum seemed to be a bit enlarged still.The next morning his scrotum was swollen and when the patient touched it, the incision opened and blood spurted.The patient went to the local er and the glued the incision with dermabond to close it and was sent to his home.At home he continued to bleed so went back to the er, they stitched the wound and discharged him home.On july 6, the patient did a follow up with his doctor by phone and the doctor told him that it was most likely infected and that he needed to have a complete revision.On july 20th the revision surgery was performed in which the inflatable penile prosthesis (ipp) was removed and replaced by a tactra.The infection was treated with an antibiotic washout.Physician believes the device did not contribute with the infection and the patient did not follow instructions using it too soon which caused an hematoma and the incision to open up.The patient is recovering from revision surgery.

Manufacturer Narrative

Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the ams 700 instructions for use (ifu).The ams 700 ifu lists infection, bleeding, swelling, dehiscence and hematoma as potential adverse events associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient was cleared to use his device on approximately (b)(6) and had successful intercourse with his wife that night.He states that she noted that his scrotum seemed to be a bit enlarged still.The next morning his scrotum was swollen and when the patient touched it, the incision opened and blood spurted.The patient went to the local er and the glued the incision with dermabond to close it and was sent to his home.At home he continued to bleed so went back to the er, they stitched the wound and discharged him home.On (b)(6), the patient did a follow up with his doctor by phone and the doctor told him that it was most likely infected and that he needed to have a complete revision.On (b)(6), the revision surgery was performed in which the inflatable penile prosthesis (ipp) was removed and replaced by a tactra.The infection was treated with an antibiotic washout.Physician believes the device did not contribute with the infection and the patient did not follow instructions using it too soon which caused an hematoma and the incision to open up.The patient is recovering from revision surgery.

Event Description

It was reported that the patient was cleared to use his device on approximately july 3 and had successful intercourse with his wife that night.He states that she noted that his scrotum seemed to be a bit enlarged still.The next morning his scrotum was swollen and when the patient touched it, the incision opened and blood spurted.The patient went to the local er and the glued the incision with dermabond to close it and was sent to his home.At home he continued to bleed so went back to the er, they stitched the wound and discharged him home.On july 6, the patient did a follow up with his doctor by phone and the doctor told him that it was most likely infected and that he needed to have a complete revision.On july 20th the replacement surgery was performed in which the inflatable penile prosthesis (ipp) system was removed and replaced by a tactra.The infection was treated with an antibiotic washout.Physician believes the device did not contribute with the infection and the patient did not follow instructions using it too soon which caused an hematoma and the incision to open up.The patient is recovering from the surgery.

Manufacturer Narrative

Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the ams 700 instructions for use (ifu).The ams 700 ifu lists infection, bleeding, swelling, dehiscence and hematoma as potential adverse events associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.The lot number of the concomitant product was unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.Additional information: concomitant product/therapy and describe event or problem.

• 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
• MDR Report Key: 12281149
• MDR Text Key: 265176614
• Report Number: 2124215-2021-23624
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• Combination Product (y/n): Y
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2023
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1000562049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESERVOIR: UPN 720185-01/LOT 1000242425
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR