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

Model Number	720074-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the malleable penile prosthesis removed due to an old implant.A new inflatable penile prosthesis (ipp) consisting of cylinders, pump, and reservoir were implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated that the patient wanted to replace from old to ipp.The patient felt it was inconvenient compare with ipp.No specific cause was found.
Additional Manufacturer Narrative
H3, h6, h10.H3 device evaluation.The spectra device was visually inspected and functionally tested.Both cylinders passed the bend test with a force readout of less than 1390 grams.Cylinder 1 performed within specification.Cylinder 2 had sharp instrument damage to the outer tube consistent with explant damage.Based on the determination that the damage was due to explant, it will not be considered a probable cause for this complaint because it is a secondary failure.The allegation of customer dissatisfaction cannot be confirmed.
Event or Problem Description
It was reported that the patient had the malleable penile prosthesis removed due to an old implant.A new inflatable penile prosthesis (ipp) consisting of cylinders, pump, and reservoir were implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated that the patient wanted to replace from old to ipp.The patient felt it was inconvenient compare with ipp.No specific cause was found.

• 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: 9368713
• Report Number: 2183959-2019-67640
• Device Sequence Number: 2287039
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2020

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: 04/14/2021
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 0131694003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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: 80 YR