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

Model Number	72404280
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inflatable penile prosthesis cylinders and pump were in a package with inhibizone sticker on the outside.This product was non-inhibizone inflatable penile prosthesis cylinders and pump.Another of the same device was used to complete the surgery.
Additional Manufacturer Narrative
Incorrect labeling was reported.The device was not returned with the outer packaging that included the alleged incorrect inhibizone labeling.The ams700 device was visually inspected and functionally tested.No leak was found.The cylinders performed within specifications.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The deflation test results were out of specification, it took greater than 14 seconds to deflate from 20 psi to 4 psi.The specification is 14 seconds or less.Review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from bsc.Product analysis could not confirm the reported labeling allegation; however allegations were concerned through (b)(4).The product record review indicated that the product met all in-process specifications prior to leaving bsc and the reported events do not represent a new or unanticipated event.The investigation conclusion code of quality control deficiency was chosen because the referenced (b)(4) confirms the allegation against the labeling.Based on the results of this investigation, this event is escalated to (b)(4).
Event or Problem Description
It was reported that the inflatable penile prosthesis cylinders and pump were in a package with inhibizone sticker on the outside.This product was non-inhibizone inflatable penile prosthesis cylinders and pump.Another of the same device was used to complete the surgery.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9107130
• Report Number: 2183959-2019-66328
• Device Sequence Number: 1924401
• Product Code: FHW
• UDI-Device Identifier: 00878953003832
• UDI-Public: 00878953003832
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2022
• Device Model Number: 72404280
• Device Catalogue Number: 72404280
• Device Lot Number: 0184172005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1