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

Model Number 72404263

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.The lot number of the concomitant was unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.

Event Description

It was reported that this inflatable penile prosthesis was removed as it suddenly stopped working due to fluid loss and air in the system.A new inflatable penile prosthesis was implanted.The old reservoir was capped and left implanted.No patient complications were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this inflatable penile prosthesis (ipp) was thoroughly analyzed.The cylinders were microscopically inspected, and functionally tested.Both cylinders had holes in the outer layer due to wear from the kink resistant tubing (krt) at the proximal and wear at a fold in the distal cylinder body.The cylinders passed leakage and pressure testing.During microscopic inspection of the pump, the krt was noted to be worn to the filament and a fluid leak was identified near the cylinder section, consistent with material fatigue.Further, the pump did not pass activation testing.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities that would affect the functionality of the device.Product analysis confirmed the reported clinical observation of fluid loss.Based on all available information, an evaluation conclusion code of cause traced to component failure was assigned to this investigation.The lot number of the concomitant was unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.

Event Description

It was reported that this inflatable penile prosthesis was removed as it suddenly stopped working due to a reservoir fluid loss and air in the system.Upon explant, it was noted that the fluid loss was most likely caused by a tear in the tubing connecting one of the cylinders.A new inflatable penile prosthesis was implanted.The old reservoir was capped and left implanted.No patient complications were reported.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.The lot number of the concomitant was unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.

Event Description

It was reported that this inflatable penile prosthesis was removed as it suddenly stopped working due to a reservoir fluid loss and air in the system.Upon explant, it was noted that the fluid loss was most likely caused by a tear in the tubing connecting one of the cylinders.A new inflatable penile prosthesis was implanted.The old reservoir was capped and left implanted.No patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086521217
• MDR Report Key: 17741004
• MDR Text Key: 323333436
• Report Number: 2124215-2023-49966
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003719
• UDI-Public: 00878953003719
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

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: 11/19/2015
• Device Model Number: 72404263
• Device Catalogue Number: 72404263
• Device Lot Number: 857086003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 11/02/2023; 12/06/2023
• Supplement Dates FDA Received: 11/27/2023; 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESERVOIR UPN: 72404155 LOT: 918542007.; RESERVOIR UPN: 72404155 LOT: 918542007.; RESERVOIR UPN: 72404155 LOT: 918542007.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male