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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for lgx 18cm is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).
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, and the reservoir was left inside the patient.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for lgx 18cm is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).Upon receipt at the quality assurance laboratory, the returned ms pump underwent a comprehensive evaluation.Microscope inspection revealed ms pump kink resistant tubing (krt) had a hole from wear, also contamination (bodily fluid) was found within the ms pump.Ms pump krt had a leak from wear, and the ms pump was not functionally tested.Additionally, the reservoir was not available for analysis; therefore, no physical analysis could be performed to this component.The reported reservoir performance allegation of hole/perforation and mechanical issue cannot be confirmed.Based on the dhr, both the reservoir and ms pump were confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.Based on the information available, without a returned reservoir available for analysis and based on this investigation, a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established was assigned to this investigation.
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, and the reservoir was left inside the patient.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: 22242148
• Report Number: 2124215-2025-39464
• Device Sequence Number: 12808520
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)240214(10)1000232137
• 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: 2019
• 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): 11/03/2025

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: 02/14/2024
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 1000232137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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: LGX 18CM UPN 72404293, LOT 1000223730.; LGX 18CM UPN 72404293, LOT 1000223730.; PUMP UPN 72404310, LOT 1000162429.; PUMP UPN 72404310, LOT 1000162429.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male