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

Model Number 72404233-12

Device Problems Collapse (1099); Failure to Cycle (1142); Infusion or Flow Problem (2964)

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

Event Date 01/06/2020

Event Type  malfunction  

Event Description

It was reported that the physician tried and not used ams 700 cx preconnect ms 21 cm pump that prepared and cycled normally at first, but after additional tests, would no longer pump.The bulb would become depressed and would not refilled.He tried doing a manual reset multiple times by holding the deactivation button, and pumping more, but the pump refused to cooperate.He did not feel comfortable implanting that pump.Instead, they opened another ams 700 cx preconnect ms 12 cm pump, and cut the pump off to hook it up to the ams 700 cx 21 cm cylinders.That pump worked as expected with the already implanted cylinders.

Manufacturer Narrative

H3, h6, h10 h3 device evaluation: product analysis confirmed a device malfunction based on the identification of a pump functional test failure.The pump failed deflation test (3) which verifies fluid is moving from the cylinder side of the pump to the reservoir side of the pump when the deflation button is not pressed and 4psi of back pressure is applied on the cylinder.Product analysis therefore concluded that this failure would affect the functionality of the device; a device malfunction was identified.

Event Description

It was reported that the physician tried and not used ams 700 cx preconnect ms 21 cm pump that prepared and cycled normally at first, but after additional tests, would no longer pump.The bulb would become depressed and would not refilled.He tried doing a manual reset multiple times by holding the deactivation button, and pumping more, but the pump refused to cooperate.He did not feel comfortable implanting that pump.Instead, they opened another ams 700 cx preconnect ms 12 cm pump, and cut the pump off to hook it up to the ams 700 cx 21 cm cylinders.That pump worked as expected with the already implanted cylinders.Additional information received indicated the pump was not cycling well intraop with slow refill and no pop.It was exchanged for new pump intraop with normal functionality.

Manufacturer Narrative

Corrected data d5.Additional information b5, d10, h3, h6.

Event Description

It was reported that the physician tried and not used ams 700 cx preconnect ms 21 cm pump that prepared and cycled normally at first, but after additional tests, would no longer pump.The bulb would become depressed and would not refilled.He tried doing a manual reset multiple times by holding the deactivation button, and pumping more, but the pump refused to cooperate.He did not feel comfortable implanting that pump.Instead, they opened another ams 700 cx preconnect ms 12 cm pump, and cut the pump off to hook it up to the ams 700 cx 21 cm cylinders.That pump worked as expected with the already implanted cylinders.Additional information received indicated the pump was not cycling well intraop with slow refill and no pop.It was exchanged for new pump intraop with normal functionality.

• 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: 9582846
• MDR Text Key: 175418115
• Report Number: 2183959-2020-00044
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1000351260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/14/2020; 02/14/2020
• Supplement Dates FDA Received: 02/12/2020; 02/24/2020
• Patient Sequence Number: 1
• Patient Age: 55 YR