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

Catalog Number 72403337

Device Problems Degraded (1153); Mechanical Problem (1384); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  Injury  

Manufacturer Narrative

Reservoir device information: serial number: (b)(4), catalog number: 72402970, expiration date: 11/25/2011, manufacture date: 12/10/2009.

Event Description

It was reported that the patient's inflatable penile prosthesis was presenting problems.The prosthesis was broken.The device was replaced due to aneurysm and a hole in the pump.This complaint was initially submitted to fda via asr report q1 2018 and additional information was received by boston scientific.Due to the removal of exemption e1997037, this information is provided via supplemental report.

Manufacturer Narrative

An analysis was performed and the results are as follows: the ams700 device was visually inspected and functionally tested.No leak was found.One cylinder and reservoir performed within specifications.The other cylinder had a bulge when inflated and broken fabric threads at a fold.The pump was not functionally tested due to the cylinder bulge and broken fabric threads.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8231158
• MDR Text Key: 132509113
• Report Number: 2183959-2019-00001
• Device Sequence Number: 1
• Product Code: FHW
• 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: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2014
• Device Catalogue Number: 72403337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention