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

Model Number	72404267
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Skin Inflammation/ Irritation (4545)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: based on the information available, there was no device available for analysis.The reported patient symptoms of fistula, erosion, and irritation is a known risk associated with an inflatable penile prosthesis implant and is noted in the device instructions for use.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.In addition, fistula, erosion, and irritation are anticipated in nature and severity based on the ifu, ams 700.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could not be performed.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the device no longer working since 2018 and the pelvic region was very irritated.During diagnostic imaging the physician observed a fistula in the urethra.The fistula was causing the patient to urinate, the connector was embedded in the in the urethra and had eroded through the scrotum.The ipp was explanted and replaced with a tactra.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported mechanical issue was unable to be confirmed through analysis.However, the, the device instructions for use describes various scenarios which can result in fistulas, erosion, and irritation.The patient device experience is included in the labeling; therefore, anticipated in nature.Technical analysis: the pump, cylinders, and reservoir were returned for analysis to our post market quality assurance laboratory.Visual examination of the pump identified the kink resistant tubing (krt) was worn down to the filament.The pump performed within all functional testing parameters.Visual examination of the cylinders identified folds in both cylinder bodies.Both cylinders had a hole in the outer tube which resulted in a small leak in the proximal cylinder bodies, resulting from sharp instrument puncture, which commonly occurs during the explant procedure.The cylinders were not functionally tested as a result of the holes and fluid loss.The reservoir performed within all visual and functional testing parameters.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.Additionally, the reported event related to fistula, erosion, and irritation are anticipated in nature and severity based on the mention of scar tissue discussed in the ifu, ams700.The reported events also do not contain an allegation against the labeling.Device history record: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the device no longer working since 2018 and the pelvic region was very irritated.During diagnostic imaging the physician observed a fistula in the urethra.The fistula was causing the patient to urinate, the connector was embedded in the in the urethra and had eroded through the scrotum.The ipp was explanted and replaced with a tactra.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: 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: 12618496
• Report Number: 2124215-2021-30726
• Device Sequence Number: 17040617
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/24/2019
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 0161832005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male