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

Model Number	72404013
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	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.During surgical intervention, a crack was identified in the right cylinder connecting tubing.All ipp components were removed, with the exception of the reservoir, which was left in place.A new ipp was subsequently implanted, and no additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: (b)(6).Serial number: n/a.Batch/lot number: 1100239083.Model/catalog description: reservoir 65ml pc.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.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.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.During surgical intervention, a crack was identified in the right cylinder connecting tubing.All ipp components were removed, with the exception of the reservoir, which was left in place.A new ipp was subsequently implanted, and no additional patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem model number/catalog number: 72404161 serial number: n/a batch/lot number: 1100239083 model/catalog description: reservoir 65ml pc unique identifier (udi) #: (b)(4) upon receipt at our quality assurance laboratory, the return components underwent a thorough analysis.The cylinder was subjected to microscopic inspection and leak testing.Microscopic examination revealed multiple holes and a cut on the proximal end of the cylinder, consistent with sharp instrument damage.Leak testing identified leakage at the proximal end of the cylinder in the area of the sharp instrument damage.The ms pump was evaluated through microscopic inspection, leak testing, and functional testing.Microscopic examination revealed a cut on the reservoir strain relief consistent with sharp instrument damage.Leak testing identified leakage at the reservoir strain relief in the area of the sharp instrument damage.The ms pump passed functional testing.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.A risk review was completed and confirmed that the event of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) 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 information available and analysis results, the reported clinical observation of device mechanical issue and tube hole/perforated, could not be confirmed.Therefore, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS 700 CXR
• 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: 25029611
• Report Number: 2124215-2026-23018
• Device Sequence Number: 15985928
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)271218(10)1100224042
• 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: 2023
• Device Explanted Year: 2026
• 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): 07/20/2026

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: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 1100224042
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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: 74 YR
• Patient Sex: Male