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

Model Number	72404250
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant a penile prosthesis for unspecified reasons.
Additional Manufacturer Narrative
D4 product details, d6a and d6b implant and explant date, c2/d10 concomitant products, e1 initial reporter phone were updated.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant a penile prosthesis for unspecified reasons.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders and pump were visually and microscopically examined, and leak tested; the cylinders were also pressure tested and the pump was also functionally tested.No anomalies were found with the cylinders.A fluid leak was found in the pump at the kink resistant tubing (krt) section of the strain relief junction.Based on the information available and analysis results, the leak identified in the pump could have caused or contributed to a device non conformance.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to explant a penile prosthesis for unspecified reasons.

• 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
• MDR Report Key: 15690975
• Report Number: 2124215-2022-44091
• Device Sequence Number: 6822421
• Product Code: FHW
• UDI-Device Identifier: 00878953003580
• UDI-Public: 00878953003580
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/07/2018
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 0137425003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 12/20/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/13/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR:UPN: 720185-01LOT: 1000033358; RESERVOIR:UPN: 720185-01LOT: 1000033358
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown