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

Model Number 720056-02

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Purulent Discharge (1812); Edema (1820); Unspecified Infection (1930); Pain (1994)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the spectra cylinders were visually and functionally tested.Both cylinders passed the bend test with a force readout of less than 1390 grams.Both cylinders had sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage and is therefore not considered a device malfunction.Product analysis was unable to confirm the reported patient allegations nor a device malfunction related to the reported events.

Event Description

It was reported that the patient had a spectra malleable penile implant surgical procedure.The patient remained hospitalized for 24 hours with intravenous antibiotherapy, ceftriaxone and gentamicin, recommended dose.He was discharged in good clinical condition with characteristic penile edema.Follow-up was performed on an outpatient basis, 48 hours after the procedure.The patient continued complaints of pain in the body of the penis and in the supra pubic area and edema was maintained, the patient was treated with other antibiotics and analgesics.After 10 days, edema was noted with an abscessed area of the back of the penis.The patient was hospitalized, cultures and analytics were taken to manage with conjecture, and treatment was applied according to the antibiogram.The patient was assessed whether to maintain the prosthesis but was not improving as there was purulent discharge from the dorsal area of the penis and suppuration, a seropurulent material.It was decided to remove the implant.During the removal of the malleable implant, a lot of purulent material and edema were noted in the penile area or ducts.15 days after the surgery for the implantation of malleable prostheses, it was removed due to the infection it presents.After it, he remains in periodic cures.Additional information received indicated two days after the prosthesis was placed the patient experienced pain, penis becomes with signs of inflammation.As well as edema in the ventral and distal part at the base of the penis.Patient reported that from the second day he felt heavy and bothered the penis and pain.Day 8 looks very puffy with collection area.Day 9 suppurates serous material and the patient with fever and a lot of pain that was managed with antibiotics, analgesics, anti-inflammatories, antipyretics and physical means.The secretion was cultivated, and e.Coli grew.Day 10 it was decided to withdraw the device.There was noted tissue lysis around the devices, very tense in the area.Suture dehiscence was noted.The wound was closed following granulation.After two weeks the culture was repeated with negative results.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9929393
• MDR Text Key: 196413792
• Report Number: 2183959-2020-01888
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005249
• UDI-Public: 00878953005249
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 720056-02
• Device Catalogue Number: 720056-02
• Device Lot Number: 1000049771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR