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

Model Number	72404282
Medical Device Problem Codes	Collapse (1099); Deflation Problem (1149); Inflation Problem (1310); Defective Device (2588); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.An attempt was made to activate the device; however, it was found that the device does not inflate nor deflate being a blockage in the tube between the reservoir and pump the suspected cause.In addition, the pump was reported to stay flat when pressed.A forced deflation maneuver was performed.The device remains implanted, and a revision surgery has not been scheduled.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.An attempt was made to activate the device; however, it was found that the device does not inflate nor deflate being a blockage in the tube between the reservoir and pump the suspected cause.In addition, the pump was reported to stay flat when pressed.A forced deflation maneuver was performed.Additional information reported that on july 5, 2024, the explant surgery was performed.It was noted that the tube from the pump to the reservoir was twisted many times on both sides.The device was removed with no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The first cylinder had wear at a fold in the middle and distal end.The first cylinder passed leakage testing.The second cylinder had a hole with a leak in the proximal end from sharp instrument damage.The momentary squeeze (ms) pump passed visual inspection, leakage testing and functional testing.The flat reservoir passed visual inspection and leakage testing.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.An attempt was made to activate the device; however, it was found that the device does not inflate nor deflate being a blockage in the tube between the reservoir and pump the suspected cause.In addition, the pump was reported to stay flat when pressed.A forced deflation maneuver was performed.Additional information reported that on (b)(6) 2024, the explant surgery was performed.It was noted that the tube from the pump to the reservoir was twisted many times on both sides.The device was removed with no additional patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.An attempt was made to activate the device; however, it was found that the device does not inflate nor deflate being a blockage in the tube between the reservoir and pump the suspected cause.In addition, the pump was reported to stay flat when pressed.A forced deflation maneuver was performed.The device remains implanted, and a revision surgery has not been scheduled.No additional 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19084557
• Report Number: 2124215-2024-20669
• Device Sequence Number: 8359212
• Product Code: FHW
• UDI-Device Identifier: 00878953003856
• UDI-Public: 00878953003856
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 02/14/2026
• Device Model Number: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1000529485
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 05/01/2024; 07/05/2024; 09/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/16/2024; 07/16/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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: 720182-01 / LOT:1100198082.; RESERVOIR: UPN: 720182-01 / LOT:1100198082.; RESERVOIR: UPN: 720182-01 / LOT:1100198082.; RESERVOIR: UPN: 720182-01 / LOT:1100198082.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male