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

Model Number	720054-02
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) was explanted due to an infection.A new device will be re-implanted "in proper time." additional information received states the spp device "failed".Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) was explanted due to an infection.A new device will be re-implanted "in proper time." additional information received states the spp device "failed." product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.It was further reported that the infection was located 0.5-1 cm below the "right side of sub-coronal." the patient experienced pain and redness two weeks after implantation.The physician believes the operative procedure may have led to the wound infection.Because the infection was related to wound healing the physician believes the infection was most likely staphylococcus.Additionally, there was no component failure.The patient was stable following the procedure.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) was explanted due to an infection.A new device will be re-implanted "in proper time." additional information received states the spp device "failed." product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.It was further reported that the infection was located 0.5-1 cm below the "right side of sub-coronal." the patient experienced pain and redness two weeks after implantation.The physician believes the operative procedure may have led to the wound infection.Because the infection was related to wound healing the physician believes the infection was most likely staphylococcus.Additionally, there was no component failure.The patient was stable following the procedure.It was further reported that a new spp cylinder was implanted on the left side on (b)(6) 2019.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) was explanted due to an infection.A new device will be re-implanted "in proper time." additional information received states the spp device "failed." product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.It was further reported that the infection was located 0.5-1 cm below the "right side of sub-coronal." the patient experienced pain and redness two weeks after implantation.The physician believes the operative procedure may have led to the wound infection.Because the infection was related to wound healing the physician believes the infection was most likely staphylococcus.Additionally, there was no component failure.The patient was stable following the procedure.It was further reported that a new spp cylinder was implanted on the left side on (b)(6) 2019.
Additional Manufacturer Narrative
Device analysis: infection and pain were reported.The spectra cylinders were visually inspected and functionally tested.One cylinder performed within specifications.One cylinder had a hole in the outer layer that was the result of sharp instrument damage consistent with explant damage.Based on the determination that the damage was due to explant the identified hole will not be considered a probable cause for this event, because it is a secondary failure.This cylinder met tested specifications.No device malfunction could be confirmed.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.Additional information: b5.

• 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: 8898371
• Report Number: 2183959-2019-65679
• Device Sequence Number: 10842460
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2019

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: 10/11/2021
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 0153060005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/18/2019; 09/18/2019; 10/07/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/10/2019; 10/04/2019; 10/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR