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

Model Number 72404233-12

Device Problem Inflation Problem (1310)

Patient Problems Hemorrhage/Bleeding (1888); Hematuria (2558); Fluid Discharge (2686)

Event Date 02/23/2022

Event Type  Injury  

Event Description

It was reported that the patient had noticed a bloody discharge from his urethra and some blood with urination four years after the inflatable penile prosthesis (ipp) implant procedure.The patient also stated that when he tried to inflate the ipp he felt a pop and then that the device would not inflate.He was advised to see his physician as soon as possible.

Manufacturer Narrative

Implant date is an estimate.Original information states that the device was implanted in the 2018.

Event Description

It was reported that the patient had noticed a bloody discharge from his urethra and some blood with urination four years after the inflatable penile prosthesis (ipp) implant procedure.The patient also stated that when he tried to inflate the ipp he felt a pop and then that the device would not inflate.He was advised to see his physician as soon as possible.

Manufacturer Narrative

Implant date is an estimate.Original information states that the device was implanted in the 2018 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: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.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 hemorrhage, altered therapeutic response and hematuria 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 had noticed a bloody discharge from his urethra and some blood with urination four years after the inflatable penile prosthesis (ipp) implant procedure.The patient also stated that when he tried to inflate the ipp he felt a pop and then that the device would not inflate.A revision surgery was scheduled.

Manufacturer Narrative

Additional information: lot number, implant date, patient identifier and date of birth.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: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.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 hemorrhage, altered therapeutic response and hematuria 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.

• 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: 13790328
• MDR Text Key: 287329744
• Report Number: 2124215-2022-07601
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2020
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1000069174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 03/28/2022; 04/25/2022
• Supplement Dates FDA Received: 03/30/2022; 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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
• Treatment: RESERVOIR: UPN 720185-01/ LOT 1000205043.
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male