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

Model Number	720074-01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole was found in a new spectra concealable penile prosthesis (spp) when the implant box was opened for a patient surgical procedure.The patient was implanted with another new spp.The product was explanted and expected to be returned.A supplemental report will be filed after the product has been returned and product analysis has been completed.
Additional Manufacturer Narrative
Cylinder hole was reported.The spectra cylinders were visually inspected and functionally tested.Both cylinders had a hole in the outer tube that was the result of a sharp instrument that exposed inner segments.Both cylinders were functional.Review of the manufacturing records for batch 159920 confirmed that there was a total of (b)(4) units started for this manufactured batch with 0 units scrapped.It can be concluded that all the finished goods components in this batch were manufactured per process and met all specifications.No labeling review, ship history, or risk review required per cis product investigation wi, (b)(4).Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered unintended use error caused or contributed to event.This complaint investigation conclusion code is utilized for the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.Based on the results of this investigation, no escalation is necessary.If further information is received at a later date, the product investigation will be reopened to address the additional information.
Event or Problem Description
It was reported that a hole was found in a new spectra concealable penile prosthesis (spp) when the implant box was opened for a patient surgical procedure.The patient was implanted with another new spp.

• 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: 8427137
• Report Number: 2183959-2019-61571
• Device Sequence Number: 11211617
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/12/2021
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 159920005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1
• Patient Age: 44 YR