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

Model Number 720054-02

Device Problems Difficult to Insert (1316); Mechanical Problem (1384)

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

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing difficulty with insertion during sexual intercourse with a spectra penile prosthesis (spp).The device cylinders were reported to bend, when having sexual intercourse.The spp was explanted, and a new spp was implanted.No patient complications were reported.

Manufacturer Narrative

Updated fields for d4 model number, d4 lot number, d4 catalog number, d4 expiration date, and d4 unique identifier.

Event Description

It was reported that the patient was experiencing difficulty with insertion during sexual intercourse with a spectra penile prosthesis (spp).The device cylinders were reported to bend, when having sexual intercourse.The spp was explanted, and a new spp was implanted.No patient complications were reported.

Manufacturer Narrative

Upon receipt of these spectra penile prosthesis (spp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination did not identify any leaks in the cylinders.Analysis identified both cylinders passed the bend test.Product analysis concluded these findings could not confirm the reported event.It was confirmed that no problem was detected with the spp.

Event Description

It was reported that the patient was experiencing difficulty with insertion during sexual intercourse with a spectra penile prosthesis (spp).The device cylinders were reported to bend, when having sexual intercourse.The spp was explanted, and a new spp was implanted.No patient complications were 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14502123
• MDR Text Key: 292719883
• Report Number: 2124215-2022-18289
• 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,Followup
• Report Date: 08/03/2022

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: 1000433900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 06/17/2022; 07/22/2022
• Supplement Dates FDA Received: 07/05/2022; 08/03/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male