MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 72400452

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced dissatisfaction with a malleable penile prosthesis (mpp).The mpp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Manufacturer Narrative

Product analysis: patient dissatisfaction was reported.The two 600m malleable cylinders were visually inspected.Both cylinders had a fractured wire bundles.Both cylinders were not functionally tested due to the fractured wire bundles.Fractured wire bundles could be a probable cause for the reported dissatisfaction with the device.Both cylinders had sharp instrument damage consistent with explant damage.Due to the determination that the damage was consistent with explant it will not be considered a probable cause for this event because it is a secondary failure.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.

Event Description

It was reported that the patient experienced dissatisfaction with a malleable penile prosthesis (mpp).The mpp was explanted and a new inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

• Brand Name: AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8804474
• MDR Text Key: 151497545
• Report Number: 2183959-2019-65139
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K912935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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 Expiration Date: 01/22/2014
• Device Model Number: 72400452
• Device Catalogue Number: 72400452
• Device Lot Number: 581309009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 09/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR