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

Model Number 720054-01

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported that the patient presented with inflammation.Two weeks later his spectra penile prosthesis (spp) device was explanted.The patient was later implanted with a new inflatable penile prosthesis (ipp) device on (b)(6) 2022.Following implantation with the ipp device the patient's condition improved.

Manufacturer Narrative

Investigation summary: with the available information boston scientific has concluded that the reported patient symptom is a known risk associated with spectra penile prosthesis procedures and is noted as such in the device instructions for use (ifu).Device analysis did not find any product issues.Device history record (dhr) review: dhr review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual examination found sharp instrument/tool damage to the outer tube in the distal cylinder bodies of both cylinders.Holes and exposed metal segments resulted from this damage, which is consistent with that sustained during explant.Both cylinders were functionally tested and passed testing, performing within specification.Product analysis did not find any device issue.Labeling review: a review of the device ifu was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Additionally, the patient symptom of inflammation was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

Event Description

It was reported that the patient presented at the clinic with inflammation.Two weeks later this spectra penile prosthesis (spp) device was explanted.The patient was later implanted with a new inflatable penile prosthesis (ipp) device.Following implantation with the ipp device the patient's condition improved.No additional 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 ; 4089353452
• MDR Report Key: 13507272
• MDR Text Key: 285422283
• Report Number: 2124215-2022-04148
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005201
• UDI-Public: 00878953005201
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 720054-01
• Device Catalogue Number: 720054-01
• Device Lot Number: 1000426551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• 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: 44 YR
• Patient Sex: Male