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

Model Number	720074-02
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this spectra penile prosthesis (spp) did not remain erect during penetration.When the prosthesis bent, it caused pain to the patient and their partner.The physician submitted a request to replace the spp with a tactra malleable prosthesis.Records do not indicate the procedure has occurred.
Additional Manufacturer Narrative
Investigation summary: based on the information available, there was no device available for analysis.The reported patient symptom is a known risk associated with spectra penile prosthesis (spp) procedures and is noted as such in the device instructions for use.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the spectra concealable penile prosthesis instructions for use (ifu).The spectra concealable penile prosthesis ifu lists pain as a potential adverse event associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that this spectra penile prosthesis (spp) did not remain erect during penetration.When the prosthesis bent, it caused pain to the patient and their partner.The physician submitted a request to replace the spp with a tactra malleable prosthesis.Records do not indicate the procedure has occurred.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13588937
• Report Number: 2124215-2022-05581
• Device Sequence Number: 14418237
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 05/11/2021
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 136305005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Male