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	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for cylinders is (b)(4).Oncomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a hole in the reservoir was identified.The cause of the hole was not detailed by the hospital.The pump was removed and replaced, and a new reservoir was placed, but the original was kept in the patient.There were no patient complications reported.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a hole in the reservoir was identified.The cause of the hole was not detailed by the hospital.The pump was removed and replaced, and a new reservoir was placed, but the original was kept in the patient.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404014 serial number: n/a batch/lot number: 1100563229 model/catalog description: cxr 18cm unique identifier (udi) #:(b)(4).Model number/catalog number: 72404310 serial number: n/a batch/lot number: 1100632370 model/catalog description: pump ms unique identifier (udi) #:(b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Mechanical issue and fluid leak are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.A risk review was completed; fluid loss, and non-functioning device issues are defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.

• 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: 22303484
• Report Number: 2124215-2025-40733
• Device Sequence Number: 8017092
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)230219(10)1000056986
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 02/19/2023
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 1000056986
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 06/21/2025
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 02/20/2018
• 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: CYLINDERS: UPN: 72404014/LOT: 1100563229; PUMP: UPN: 72404310/LOT: 1100632370
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male