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

Model Number	720054-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Perforation (2001); Complaint, Ill-Defined (2331); Injury (2348)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Additional information provided in: b5, d10, h6.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8939106
• Report Number: 2183959-2019-65883
• Device Sequence Number: 19370776
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/02/2019; 10/07/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/13/2019; 10/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR