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

Model Number	72404291
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device: model number: 72404310, lot number: 0174306002, model description: pump ms.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) cylinders and pump were explanted because the tubing between the cylinders and pump had become disconnected.New 15cm x 12mm cylinders and a new pump were implanted.It was further reported that the cause of the disconnection of the tubing was not found.In addition to the disconnection there was fluid loss from the device.Two weeks prior to surgery the patient had difficulty inflating and deflating the device due to the fluid loss.The patient was doing well following the 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.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) cylinders and pump were explanted because the tubing between the cylinders and pump had become disconnected.New 15cm x 12mm cylinders and a new pump were implanted.It was further reported that the cause of the disconnection of the tubing was not found.In addition to the disconnection there was fluid loss from the device.Two weeks prior to surgery the patient had difficulty inflating and deflating the device due to the fluid loss.The patient was doing well following the 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.
Additional Manufacturer Narrative
Device evaluation: the complaint component was returned and analyzed, and the reported allegation of fluid leak was confirmed via product analysis.Based on the results of this investigation, no escalation is necessary.Cylinders 1 and 2 were visually, functionally, and leak tested.Neither cylinder presented any damage or leaks.The pump was visually and leak tested.A pump leak was identified in the cylinder krt at the pump strain relief junction due to fatigue.Model number: 72404310, lot number: 0174306002, model description: pump ms.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8520499
• Report Number: 2183959-2019-62308
• Device Sequence Number: 1629235
• Product Code: FHW
• UDI-Device Identifier: 00878953003931
• UDI-Public: 00878953003931
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/04/2021
• Device Model Number: 72404291
• Device Catalogue Number: 72404291
• Device Lot Number: 0146385004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR