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

Model Number	720056-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a revision of his inflatable penile prosthesis (ipp) device due to unspecified reasons.The patient is now experiencing pain in his penis.
Event or Problem Description
It was reported that the patient had a revision of his inflatable penile prosthesis(ipp) device due to unspecified reasons.The patient is now experiencing pain in his penis.
Additional Manufacturer Narrative
D4 product details corrected the spectra cylinders were visually and functionally tested.Both cylinders had sharp instrument/tool damage to the outer tube in cylinder body, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage.Both cylinders were functional tested and passed the bend teste with a force readout of less than 1390 grams.The cylinders therefore performed within specification.The product record review confirmed the reported events of pain do not represent an unanticipated event nor did the device fail to meet applicable product specifications prior to shipment from boston scientific.An investigation conclusion code of known inherent risk of device was chosen because a product malfunction was not identified with the returned spectra and the adverse event of pain is included in the product labeling.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.The product analysis results and event report provided no objective evidence that would warrant further escalation.

• 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: 10299707
• Report Number: 2183959-2020-03057
• Device Sequence Number: 19574071
• Product Code: FAE
• UDI-Device Identifier: 00878953003849
• UDI-Public: 00878953003849
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/22/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/11/2022
• Device Model Number: 720056-02
• Device Catalogue Number: 720056-02
• Device Lot Number: 1000022893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other