MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 SPHERICAL RESERVOIR; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404161
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the reservoir had a hole.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for cxr 14cm is (b)(4).
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for cxr 14cm is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Visual inspection revealed both cylinders passed without damage or abnormalities.Leakage testing confirmed both cylinders passed.The spherical reservoir had a hole from sharp instrument damage, not passing the visual inspection test; therefore, it was not leak tested.Under microscope observation, contamination (bodily fluid) was found within the ms pump, not passing the test.Leakage testing showed the ms pump passed.Functional testing was not performed on the ms pump to avoid damaging the test equipment.Based on the available information and analysis, the sharp instrument damage is considered a secondary issue, and the allegation of mechanical issue could not be confirmed.However, several potential failure modes could lead to a mechanical issue, including but not limited to device malfunction; therefore, a conclusion code of cause not established was assigned.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the reservoir had a hole.The device was explanted and replaced.There were no patient complications.

• Brand Name: AMS 700 SPHERICAL RESERVOIR
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• 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: 22179264
• Report Number: 2124215-2025-37523
• Device Sequence Number: 9189179
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)220710(10)178402013
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 07/10/2022
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 0178402013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2017
• 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: CXR 14CM LOT 0190579001, UPN 72404012; CXR 14CM LOT 0190579001, UPN 72404012; PUMP LOT 1000076870, UPN 72404310; PUMP LOT 1000076870, UPN 72404310
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male