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

Model Number	720054-02
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this spectra penile prosthesis (spp) underwent a surgical procedure to remove the device.The device was too small for the correct fit in the corpora and caused the cylinders to become individually twisted.The existing spp was explanted and replaced with a new device.No patient complications were reported.
Additional Manufacturer Narrative
Investigation summary based on the information available, the cause that contributed to the reported allegation cannot be established as the product is not available for analysis.Device history record (dhr) the device history record (dhr) 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.The reported device performance allegation cannot be confirmed.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.The ifu states proper sizing of the device is critical to a successful outcome.Improper measurement, inappropriate cylinder size selection, or malpositioning of the cylinders within the corpora cavernosa may result in migration or buckling of the cylinders or reduce cylinder life.Investigation conclusion based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that the patient implanted with this spectra penile prosthesis (spp) underwent a surgical procedure to remove the device.The device was too small for the correct fit in the corpora and caused the cylinders to become individually twisted.The existing spp was explanted and replaced with a new device.No patient complications were reported.

• 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: 12897245
• Report Number: 2124215-2021-36735
• Device Sequence Number: 3899954
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/02/2021
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 121617005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male