MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE

Model Number 720081-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to replace this tactra malleable penile prosthesis with an inflatable penile prosthesis (ipp) for unspecified reasons.The patient outcome was not reported.Additional information was received indicating the tactra device was replaced due to patient dissatisfaction with the feel of the malleable device.The patient was stable following the procedure.

Event Description

It was reported that the patient underwent a surgical procedure to replace this tactra malleable penile prosthesis with an inflatable penile prosthesis (ipp) for unspecified reasons.The patient outcome was not reported.Additional information was received indicating the tactra device was replaced due to patient dissatisfaction with the feel of the malleable device.The patient was stable following the procedure.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes as no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.Device technical analysis: the tactra cylinders were visually inspected and functionally tested.Sharp instrument damage consistent with explant damage was present on one cylinder.This damage is considered a secondary failure and is not the cause of the complaint.Both cylinders passed all bend tests with force readouts of less than 4.50 lbs.Both cylinders passed all position tests with force readouts of less than 1.90 lbs.Both cylinders had a compliance value between 0.019 and 0.720 mm/n, (0.0033 and 0.126 in/lb) when a load was applied across the diameter to the distal (non-tapered) portion of the device.Both cylinders' distal tips and rear tip extenders had a compliance value between 0.019 and 0.720 mm/n, (0.0033 and 0.126 in/lb) when a load was applied axially.Product analysis therefore confirmed there was not a device malfunction with the cylinders; the cylinders performed within specification.An investigation conclusion code of no problem detected was chosen as no malfunction was found due to a design or manufacturing issue.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Risk review: a review of the tactra hazard analysis was completed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to device labeling.The manual was unlikely to be the cause of the reported complaint.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10427953
• MDR Text Key: 203645389
• Report Number: 2183959-2020-03611
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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: Lay User/Patient
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0024084588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 08/16/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR