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

Model Number	720054-01
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician measured 16.5cm and used 12 cm x 9.5mm cylinder with rear tips of 1.5 cm and 3 cm.The physician used it to make the incision smaller during insertion, and the surface of cylinder was torn in the process of putting in the cylinder hard.They did not have the same size, so the physician asked for preparation of a 16 cm x 9.5 mm with a rear tip 0.5 cm to finished the surgery.The event resolved and the patient was stable.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The complaint component was returned and analyzed.The reported allegations was confirmed via product analysis cylinders.Functional testing revealed cylinder 1 passed all testing.Cylinder 2 had a hole in the outer tube due to interaction with a sharp instrument.Cylinder 2 also had metal segments exposed.No escalation to ncep, capa, or scar is required.
Event or Problem Description
It was reported that the physician measured 16.5cm and used 12 cm x 9.5mm cylinder with rear tips of 1.5 cm and 3 cm.The physician used it to make the incision smaller during insertion, and the surface of cylinder was torn in the process of putting in the cylinder hard.They did not have the same size, so the physician asked for preparation of a 16 cm x 9.5 mm with a rear tip 0.5 cm to finished the surgery.The event resolved and the patient was stable.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8682778
• Report Number: 2183959-2019-63822
• Device Sequence Number: 19398147
• Product Code: FAE
• UDI-Device Identifier: 00878953005201
• UDI-Public: 00878953005201
• 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
• Report Date (Section B): 07/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2022
• Device Model Number: 720054-01
• Device Catalogue Number: 720054-01
• Device Lot Number: 0174825001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR