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

Model Number	720074-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) device was explanted because both cylinders were broken.The device issues began in (b)(6) 2020.A new spp device was implanted.After the surgery the patient has been seen every day to evaluate is condition and ensure there is no infection.
Event or Problem Description
It was reported that the spectra penile prosthesis (spp) device was explanted because both cylinders were broken.The device issues began in (b)(6) 2020.A new spp device was implanted.After the surgery the patient has been seen every day to evaluate is condition and ensure there is no infection.
Additional Manufacturer Narrative
Additional information and device evaluation provided in: d10, h3, h6 and h10.Device evaluation: the spectra cylinders were visually inspected.The cylinder body of both cylinders were identified to be cut in half that was the result of sharp instrument/tool damage.Both cylinders were not functionally test due to the damage.These damages are consistent with explant damage and were considered a secondary failure.Product analysis was unable to confirm the reported events.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.There is no evidence that the reported events are related to a manufacturing deficiency based on the product analysis and a review of the manufacturing records.

• 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: 10751658
• Report Number: 2183959-2020-05168
• Device Sequence Number: 19104207
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/17/2020
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 101329003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR