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

Model Number 72404155

Device Problems Degraded (1153); Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/21/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to the reservoir was full of clots and both cylinders were damaged with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.

Manufacturer Narrative

Reservoir analysis: an allegation of device malfunction and foreign material was made.The ams700 ipp reservoir were visually inspected and functionally tested.The reservoir performed within specification.Product analysis could not confirm the reported events.Cylinder analysis: product analysis was unable to confirm the reported allegation related to cylinders damaged and degraded as sharp instrument damage was identified.The ams700 ipp cylinders were visually inspected and functionally tested.Both cylinders had leak in cylinder body that was result of sharp instrument damage which occurred during the explant; holes were present.These damages were consistent with explant damage and were considered a secondary failure.Both cylinders had wear at fold in cylinder body.

Event Description

It was reported that the patient underwent a revision procedure due to the reservoir was full of clots and both cylinders were damaged with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.

• 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: 10278073
• MDR Text Key: 198940156
• Report Number: 2183959-2020-02933
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003207
• UDI-Public: 00878953003207
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2013
• Device Model Number: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 703066012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 09/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention