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); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to pump problem with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir were implanted.

Event Description

It was reported that the patient underwent a revision procedure due to pump problem, the patient could not manipulate the pump properly and the pump would collapse often.With an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir were implanted.The patient recovered following the procedure and the patient was provided with techniques to prevent this issue.

Event Description

It was reported that the patient underwent a revision procedure due to pump problem, pump would collapse often, and the patient could not manipulate the pump properly with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir were implanted.The patient recovered and was provided with techniques to prevent this issue.

Manufacturer Narrative

Device analysis: the returned device was analyzed and the reported allegations of pump problem, pump collapse, and unable to manipulate the pump was confirmed.Based on a review of all available information, the cause of the reported event was determined to be failure of the activation test.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.Based on the results of this investigation, no escalation is required.

• 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: 9897720
• MDR Text Key: 186673618
• Report Number: 2183959-2020-01687
• 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,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2022
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0174300009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/26/2020; 05/11/2020
• Supplement Dates FDA Received: 04/06/2020; 05/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR