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

Model Number	72404156
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404433.Serial number: n/a.Batch/lot number: 1100840097.Model/catalog description: cx preconnect tenacio 21cm ps, iz.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited a reservoir migration, which resulted in a bowel obstruction.A surgical procedure was performed during which the reservoir was removed.It was also noted that the cylinders were left semi-inflated, and a metal cap was placed on the cylinder tubing just beneath the abdominal counter incision.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited a reservoir migration, which resulted in a bowel obstruction.A surgical procedure was performed during which the reservoir was removed.It was also noted that the cylinders were left semi-inflated, and a metal cap was placed on the cylinder tubing just beneath the abdominal counter incision.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404433, serial number: n/a, batch/lot number: 1100840097, model/catalog description: cx preconnect tenacio 21cm ps, iz, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The reported patient symptoms of bowel obstruction and migration were found to be listed in the ifu.A risk review was completed and confirmed that the event of obstruction, bowel, and migration was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the available information a conclusion code of known inherent risk of device 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: 24818373
• Report Number: 2124215-2026-19079
• Device Sequence Number: 12265037
• Product Code: JCW
• UDI-Device Identifier: 00878953003214
• UDI-Public: (01)00878953003214(17)270328(10)1100701158
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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 Model Number: 72404156
• Device Catalogue Number: 72404156
• Device Lot Number: 1100701158
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 03/28/2025
• 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: 72 YR
• Patient Sex: Male