MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 Spherical Reservoir; prosthesis, penis, inflatable

Model Number	72404156
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was unable to inflate the device.During revision surgery, no fluid was observed moving into the cylinders.The device was disconnected from the reservoir, and surrogate testing was performed, after which the cylinders inflated.An attempt was made to aspirate fluid from the reservoir; however, no fluid could be retrieved.As a result, the reservoir was capped and retained in situ, and a new reservoir was implanted on the left side.Following implantation of the new reservoir, the device inflated properly.No patient complications were reported.
Additional Manufacturer Narrative
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.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.Model number/catalog number: 72404433.Serial number: n/a.Batch/lot number: 1100767343.Model/catalog description: cx preconnect tenacio 21cm ps, iz.Unique identifier (udi) #: (b)(4).

• 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: 50123761
• Report Number: 2124215-2026-41562
• Device Sequence Number: 5598635
• Product Code: JCW
• UDI-Device Identifier: 00878953003214
• UDI-Public: (01)00878953003214(17)270703(10)1100755553
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404156
• Device Catalogue Number: 72404156
• Device Lot Number: 1100755553
• 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: 07/07/2026
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 07/03/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male