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

Model Number 72404310

Device Problems Break (1069); Collapse (1099); Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

Estimated date was entered because exact date of event was not provided.

Event Description

It was reported that the inflatable penile prosthesis (ipp) pump was explanted due to fluid loss from a broken connector between the pump and the reservoir.A new ipp pump was implanted.It was further reported that two weeks prior to surgery the pump stayed flat and was not working.The patient was doing well following surgery.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.

Manufacturer Narrative

Device evaluation: the complaint component was returned and analyzed, and the reported allegation of malfunction was confirmed via product analysis.Based on the results of this investigation, no escalation is necessary.Additional manufacturer narrative: estimated date was entered because exact date of event was not provided.

Event Description

It was reported that the inflatable penile prosthesis (ipp) pump was explanted due to fluid loss from a broken connector between the pump and the reservoir.A new ipp pump was implanted.It was further reported that two weeks prior to surgery the pump stayed flat and was not working.The patient was doing well following surgery.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.

• 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: 8545314
• MDR Text Key: 142934077
• Report Number: 2183959-2019-62493
• 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: 06/18/2019

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: 01/12/2021
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 115942005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 06/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR