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

Model Number 720054-02

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to replace this spectra malleable penile prosthesis due to poor rigidity and quality of erections preventing intercourse.The existing device was explanted and an inflatable penile prosthesis (ipp) was implanted in its place.No patient complications were reported.The explanted components are expected for return.

Manufacturer Narrative

Product investigation: the complaint component was returned and analyzed, and the reported allegation of poor rigidity was not confirmed via product analysis.The spectra cylinders were visually inspected and functionally tested.Both cylinders performed within specifications.The product record review indicated that the product met all in-process specifications prior to leaving bsc and the reported events do not represent a new or unanticipated event.The investigation conclusion code of no problem detected was chosen because a device complaint or malfunction could not be confirmed through product analysis.Based on the results of this investigation, no escalation to ncep/capa/scar is required.

Event Description

It was reported that the patient underwent a surgical procedure to replace this spectra malleable penile prosthesis due to poor rigidity and quality of erections preventing intercourse.The existing device was explanted and an inflatable penile prosthesis (ipp) was implanted in its place.No patient complications were reported.The explanted components are expected for return.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8924081
• MDR Text Key: 155317432
• Report Number: 2183959-2019-65810
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2022
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 0178246005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR