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

Model Number	720054-02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace this spectra malleable penile prosthesis due to poor rigidity and quality of erections preventing intercourse.The existing device was explanted and an inflatable penile prosthesis (ipp) was implanted in its place.No patient complications were reported.The explanted components are expected for return.
Additional Manufacturer Narrative
Product investigation: the complaint component was returned and analyzed, and the reported allegation of poor rigidity was not confirmed via product analysis.The spectra cylinders were visually inspected and functionally tested.Both cylinders performed within specifications.The product record review indicated that the product met all in-process specifications prior to leaving bsc and the reported events do not represent a new or unanticipated event.The investigation conclusion code of no problem detected was chosen because a device complaint or malfunction could not be confirmed through product analysis.Based on the results of this investigation, no escalation to ncep/capa/scar is required.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace this spectra malleable penile prosthesis due to poor rigidity and quality of erections preventing intercourse.The existing device was explanted and an inflatable penile prosthesis (ipp) was implanted in its place.No patient complications were reported.The explanted components are expected for return.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8924081
• Report Number: 2183959-2019-65810
• Device Sequence Number: 2048324
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 06/06/2022
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 0178246005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 YR