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

Model Number 720074-02

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2021

Event Type  malfunction  

Event Description

It was reported that during an implant procedure for a spectra penile prosthesis (spp), the size was missing.The procedure was not completed due to this event.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the visual and functional testing performed did not identify any leaks or abnormalities that could affect the functionality of the device; therefore, the reported allegations were unable to be confirmed.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The rear tip extenders were visually inspected and no issues were found, the device appeared to be in good conditions.Visual examination did not find any damage in the cylinders.Functional testing of the device showed that the cylinders performed within specification.Labeling review: 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.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that during an implant procedure for a spectra penile prosthesis (spp), the size was missing.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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
• MDR Report Key: 11948443
• MDR Text Key: 254569023
• Report Number: 2124215-2021-15826
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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 Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 1000417828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR