MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700? CX TENACIO? Pump; prosthesis, penis, inflatable

Model Number	72404434
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) had reported needing 70 to 100 pumps to achieve an erection and had previously experienced difficulty inflating the device during evaluations by a health care professional (hcp).After confirming the proper technique, the device still required 20 to 30 compressions to transfer fluid and achieve an erection.A replacement surgery was performed in (b)(6) 2025 in which physician confirmed the tenacio pump issues, describing difficulty in pumping and implanted a ms pump.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Correction to h7 if remedial act init, type correction to h9 correction/removal reporting #.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) had reported needing 70 to 100 pumps to achieve an erection and had previously experienced difficulty inflating the device during evaluations by a health care professional (hcp).After confirming the proper technique, the device still required 20 to 30 compressions to transfer fluid and achieve an erection.A replacement surgery was performed in (b)(6) 2025 in which physician confirmed the tenacio pump issues, describing difficulty in pumping and implanted a ms pump.There were no patient complications.

• Brand Name: AMS 700? CX TENACIO? Pump
• 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 ; +1(508)652-1217
• MDR Report Key: 23191663
• Report Number: 2124215-2025-66069
• Device Sequence Number: 18425691
• Product Code: JCW
• UDI-Device Identifier: 00191506021351
• UDI-Public: (01)00191506021351(17)261025(10)1100619616
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2026

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: 72404434
• Device Catalogue Number: 72404434
• Device Lot Number: 1100619616
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 08/13/2026
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 01/20/2026; 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0142-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR LOT 1100723805, UPN 72018501.; RESERVOIR LOT 1100723805, UPN 72018501.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male