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

Model Number 720054-02

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  Injury  

Event Description

It was reported, that the patient underwent a procedure.To remove the ams spectra concealable penile prosthesis, because the device was bending.The device was replaced with a tactra malleable penile prothesis.There were no patient complications reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned device underwent a thorough analysis.Noth cylinders were visually inspected, and functionally tested.Visual examination revealed that both cylinders had holes in the distal of their bodies with internal component exposed, consistent with explant damage.In addition, it was noted that there were yellow specks on the body of cylinder 1.Both cylinders passed the functional inspection.Based on the information available and analysis results, the reported clinical observation of device bending could not be confirmed; therefore, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient underwent a procedure to remove the ams spectra concealable penile prosthesis because the device was bending.The device was replaced with a tactra malleable penile prothesis.There were no patient complications reported.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17131443
• MDR Text Key: 317203013
• Report Number: 2124215-2023-30688
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000433930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male