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

Model Number 72404310

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to the device not working properly two weeks prior to the revision procedure with an inflatable penile prosthesis (ipp).Diagnostic testing found that when the pump was pressed it was difficult to press.The ipp pump was explanted and a new ipp pump was implanted.The patient was stable following the procedure.

Manufacturer Narrative

The returned device was analyzed and the reported allegations of a pump malfunction was confirmed.Based on a review of all available information, the cause of the reported event was due to the pump failing the activation test.

Event Description

It was reported that the patient underwent a revision procedure due to the device not working properly two weeks prior to the revision procedure with an inflatable penile prosthesis (ipp).Diagnostic testing found that when the pump was pressed it was difficult to press.The ipp pump was explanted and a new ipp pump was implanted.The patient was stable following the procedure.

• 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
• MDR Report Key: 10642671
• MDR Text Key: 210212647
• Report Number: 2183959-2020-04452
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000280270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR