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

Model Number 720185-01

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/27/2019

Event Type  malfunction  

Event Description

It was reported that at the commencement of an inflatable penile prosthesis procedure, when the scrub nurse had been requested to open and prepare the ams700 conceal reservoir, it was noted that inside the sealed sterile packaging (adjacent to the implant) was a piece of foreign light black material that appeared loose.The surgeon requested that this implant therefore not be used and another conceal reservoir was opened and used (with no foreign body in the packaging) no issues were reported in relation to the event.

Manufacturer Narrative

H3 device evaluation: the complaint component was returned and analyzed.The packaging was returned with the seal being opened the whole length of the package on both sides.A loose black material was visible.Unable to confirm if the foreign material was due to a manufacturing issue as the package was returned open.The reservoir performed within specifications.No escalation to ncep, capa, or scar is required.

Event Description

It was reported that at the commencement of an inflatable penile prosthesis procedure, when the scrub nurse had been requested to open and prepare the ams700 conceal reservoir, it was noted that inside the sealed sterile packaging (adjacent to the implant) was a piece of foreign light black material that appeared loose.The surgeon requested that this implant therefore not be used and another conceal reservoir was opened and used (with no foreign body in the packaging) no issues were reported in relation to the event.

• 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: 8460942
• MDR Text Key: 140197460
• Report Number: 2183959-2019-61875
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1000209633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 08/01/2019
• Patient Sequence Number: 1
• Patient Age: 69 YR