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

Model Number	72404281
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had this tactra removed and replaced due to an unspecified mechanical issue.No patient complications were reported.
Event or Problem Description
It was reported that the patient had this inflatable penile prosthesis (ipp) removed and replaced due to fluid loss.No patient complications were reported.
Additional Manufacturer Narrative
Correction to the initial mdr in b5: event description, d1: brand name, d2a: common device name, d2b: pro code (product code), d4: model number, d4: lot number, d4: catalog number, d4: expiration date, d4: unique identifier (udi), g1: mfr site address 1, g1: mfr site city, g1: mfr site country.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined, and leak tested.Both cylinders had wear at folds in the proximal cylinder bodies.The first cylinder had a leak at the corner of a fold in the proximal cylinder body.The second cylinder had a leak in the middle and distal end of the cylinder body, consistent with explant damage.The pump was visually and microscopically examined, and leak tested.The pump had a leak at the kink resistant tubing (krt) consistent with explant damage.Contamination was observed within the pump under microscopic examination; therefore, the pump was not functionally tested.Based on the information available and analysis results, the fluid leak identified in the first cylinder could have caused or contributed to the reported clinical observation of fluid loss.
Event or Problem Description
It was reported that the patient had this inflatable penile prosthesis (ipp) removed and replaced due to fluid loss.No patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 15712771
• Report Number: 2124215-2022-44863
• Device Sequence Number: 17374379
• Product Code: FHW
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2023
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1000002556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 01/20/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/07/2022; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: 72404161/0182050017; RESERVOIR: 72404161/0182050017
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male