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

Model Number 720054-02

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 07/31/2019

Event Type  Injury  

Event Description

It was reported that the spectra penile prosthesis (spp) implant surgery was suspended due to urethral injury during the surgery."the cylinder and rte 5cm were just used and there's no any implantation." additional information received states the cause of the urethral injury was not specified but "the urethra of the patient was not healthy" during the surgery.There were no further complications as a result of this event.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.

Manufacturer Narrative

Additional information provided in: b5, d10, h6.

Event Description

It was reported that the spectra penile prosthesis (spp) implant surgery was suspended due to urethral injury during the surgery."the cylinder and rte 5cm were just used and there's no any implantation." additional information received states the cause of the urethral injury was not specified but "the urethra of the patient was not healthy" during the surgery.There were no further complications as a result of this event.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.It was further reported that the urethral injury was "a perforation of the urethra during surgery." it was also clarified that what was meant by "the urethra was not healthy" meant that the urethra was injured "with external way" which was related to the implant procedure.

Manufacturer Narrative

Device analysis: no malfunction was reported.The spectra cylinders were visually inspected and functionally tested.Both cylinders performed within specifications.The returned device had no influence on this event.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.Additional information provided in: b5, d10, h6.

Event Description

It was reported that the spectra penile prosthesis (spp) implant surgery was suspended due to urethral injury during the surgery."the cylinder and rte 5cm were just used and there's no any implantation." additional information received states the cause of the urethral injury was not specified but "the urethra of the patient was not healthy" during the surgery.There were no further complications as a result of this event.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.It was further reported that the urethral injury was "a perforation of the urethra during surgery." it was also clarified that what was meant by "the urethra was not healthy" meant that the urethra was injured "with external way" which was related to the implant procedure.

• 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: 8939106
• MDR Text Key: 155784994
• Report Number: 2183959-2019-65883
• 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,Followup
• Report Date: 10/16/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000155812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/02/2019; 10/07/2019
• Supplement Dates FDA Received: 09/13/2019; 10/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR