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

Model Number 720074-02

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Event Description

It was reported that during replacement procedure of an inflatable penile prosthesis (ipp) device, a spectra penile prosthesis (spp) cylinder cracked so it was replaced with a new spp device.No adverse patient effects.Additional information was receive.Device outer layer cracked while being manipulated into the patient.Physician believes it cracked while bending to insert into patient.

• 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
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS LLC; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9670465
• MDR Text Key: 177774802
• Report Number: 2183959-2020-00440
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/17/2022
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 0170503001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR