MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPECTRA; PROSTHESIS PENILE

Model Number	720074-02
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this spectra penile prosthesis (spp) became soft, there was no possibility of penetration, it kept folding and became soft.The spp was explanted and replaced with a tactra device.No additional information was reported.
Event or Problem Description
It was reported that this spectra penile prosthesis (spp) became soft, there was no possibility of penetration, it kept folding and became soft.The spp was explanted and replaced with a tactra device.No additional information was reported.
Additional Manufacturer Narrative
Updated evaluation conclusion codes h6.
Event or Problem Description
It was reported that this spectra penile prosthesis (spp) became soft, there was no possibility of penetration, it kept folding and became soft.The spp was explanted and replaced with a tactra device.No additional information was reported.
Additional Manufacturer Narrative
Updated evaluation conclusion codes h6.Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Both cylinders passed visual inspection and functional tests.This investigation was assigned to the conclusion code of cause not established.

• Brand Name: SPECTRA
• Common Device Name: PROSTHESIS PENILE
• 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: 21124163
• Report Number: 2124215-2024-83500
• Device Sequence Number: 7474041
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: (01)00878953005287(11)190219(17)240218(10)1000233629
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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: 02/18/2024
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 1000233629
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 04/01/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/30/2025; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male