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

Model Number 720054-02

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced a revision of an spectra penile prosthesis(spp) cylinder due to the length being too short.A patient outcome of stable was reported.

Manufacturer Narrative

The spectra cylinders were visually and functionally tested.Cylinder 1 performed within specification.Cylinder 2 had sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage.Due to this damage being consistent with explant it will be considered a secondary failure.Both cylinders passed the bend test with a force readout of less than 1390 grams.Therefore, product analysis was unable to confirm the reported events.The product record review indicated reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of no problem detected was chosen because the reported events could not be confirmed or substantiated through investigation.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that the patient experienced a revision of an spectra penile prosthesis(spp) cylinder due to the length being too short.A patient outcome of stable was reported.

• 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: 10069440
• MDR Text Key: 191380867
• Report Number: 2183959-2020-02278
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000218754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 06/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 63 YR