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

Model Number	720074-01
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced the pump not inflating with a spectra penile prosthesis (spp).The spp was explanted and a new cxr inflatable penile prosthesis (ipp) was implanted.During the implant procedure, the first cylinder that was attempted was not implanted due to measurement error and the cylinder was too thick to advance to the corpus cavernosum and a new ipp cylinder was implanted.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Device analysis: inflation issues 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 tool damage consistent with explant damage.This cylinder was functional.The product record review revealed no additional information related to the complaint so an overall investigation conclusion code of no problem detected was chosen as the reported device problem cannot be confirmed.The reported allegation(s) could not be confirmed.No escalation to ncep, capa, or scar is required, complaints are monitored for escalation of systemic issues through the trending process per the cis product investigation work instruction.
Event or Problem Description
It was reported that the patient experienced the pump not inflating with a spectra penile prosthesis (spp).The spp was explanted and a new cxr inflatable penile prosthesis (ipp) was implanted.During the implant procedure, the first cylinder that was attempted was not implanted due to measurement error and the cylinder was too thick to advance to the corpus cavernosum and a new ipp cylinder was implanted.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8148665
• Report Number: 2183959-2018-61503
• Device Sequence Number: 1684075
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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: 06/13/2021
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 0141128001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 06/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR