MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number 72404251

Device Problems Collapse (1099); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/28/2020

Event Type  Injury  

Event Description

It was reported that the patient was having a difficult time pumping up an inflatable penile prosthesis (ipp).A replacement surgery was performed in which the existing device was removed and a new system was implanted.The patient fully recovered following the procedure.

Event Description

It was reported that the patient was having a difficult time pumping up an inflatable penile prosthesis (ipp) as the pump was staying flat when pumped.The patient was said to be dissatisfied with the implant leading to the procedure.A replacement surgery was performed in which the existing device was removed and a new system was implanted.The patient fully recovered following the procedure.

Manufacturer Narrative

Updated: b5, d10, h3, h6.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 ams700 ipp cylinders were visually inspected and functionally tested.Both cylinders had wear at folds in cylinder body; no leak was found in cylinder 2.Cylinder 1 has leak in the proximal cylinder body that result of sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.Product analysis concluded these activation issues could affect the functionality of the pump; therefore, product analysis confirmed pump malfunction.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.The ams 700 flat reservoir was visually inspected and functionally tested; no leaks were found.The reservoir therefore performed within specification.Product analysis was unable to confirm the reported event.Based on the event details and the visual inspection, product analysis concluded there was not a device malfunction with the reservoir returned.Risk review: a review of the ams 700 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: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10696624
• MDR Text Key: 211865297
• Report Number: 2183959-2020-04808
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003597
• UDI-Public: 00878953003597
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2020
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 1000030320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 10/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR