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

Model Number 720074-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulcer (2274); Discomfort (2330)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that a patient implanted with this spectra penile prosthesis (spp) started experiencing discomfort during ongoing use of the device and noted that their glans looked as if it had ulcerated, which led to a clinical evaluation.The physician removed the spp and performed a biopsy in the affected area.The patient was expected to fully recover from the procedure.No additional information was reported.Boston scientific has been unable to obtain additional information regarding the patient biopsy results, despite good faith efforts.

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risks associated with spp procedures and are noted as such in the spp instructions for use.Device history record (dhr): the dhe confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the spp instructions for use (ifu) was reviewed.The patient symptoms of tissue damage were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: 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: 13386447
• MDR Text Key: 284641276
• Report Number: 2124215-2022-02230
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: 00878953005294
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 0184707004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male