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

Model Number 72404282

Device Problems Deflation Problem (1149); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

Component analysis.This record is a non-complaint product return (ncpr); no device allegation has been reported.The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders performed within specification.The ams 700 momentary squeeze (ms) pump was also visually inspected; no leaks were found.The pump was functionally tested and failed the deflation and activation test.There was not a device allegation reported; however, product analysis identified a device malfunction.

Event Description

It was reported that the physician opened a preconnected cx 18 cm cylinder by mistake.No other device or patient allegations were alleged.Ncpr is escalated to a complaint based on a product malfunction identified during the product analysis.The pump was functionally tested and failed the deflation and activation test.There was not a device allegation reported; however, product analysis identified a device malfunction.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9629275
• MDR Text Key: 176972763
• Report Number: 2183959-2020-00238
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003856
• UDI-Public: 00878953003856
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2023
• Device Model Number: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1000197036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR