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

Model Number	720074-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had a spectra penile prosthesis implanted on (b)(6) 2018 at which time they only implanted the right cylinder.The left cylinder was not implanted.The spectra prosthesis is designed to be implanted as a pair of matched cylinders.A single implanted cylinder may not be adequate to achieve sexual intercourse and may have an adverse effect on the reliability of the device.
Additional Manufacturer Narrative
The product investigation results confirmed the as reported observations and an overall investigation conclusion code of unintended use error caused or contributed to event was selected as the problem is traced to the interaction between the user and the device and it is unknown if the doctor intentionally didn't follow the labeling,.Escalation to ncep/capa is not required as this is an isolated occurrence with this physician and will continue to monitor.
Event or Problem Description
It was reported the patient had a spectra penile prosthesis implanted on (b)(6) 2018 at which time they only implanted the right cylinder.The left cylinder was not implanted.The spectra prosthesis is designed to be implanted as a pair of matched cylinders.A single implanted cylinder may not be adequate to achieve sexual intercourse and may have an adverse effect on the reliability of the device.

• 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: 7960832
• Report Number: 2183959-2018-60161
• Device Sequence Number: 16564411
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/02/2022
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 0168014004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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: Other
• Patient Age: 67 YR