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

Model Number 72404251

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Purulent Discharge (1812); Fever (1858); Pain (1994); Sepsis (2067); Swelling/ Edema (4577)

Event Date 11/01/2020

Event Type  Injury  

Event Description

It was reported that the patient developed an infection following implant of this inflatable penile prosthesis (ipp).Antibiotic treatment proved ineffective and their condition worsened.The patient subsequently underwent an urgent procedure to explant the ipp due to concerns of sepsis.No additional information was reported.

Manufacturer Narrative

The following fields have been updated based upon the receipt of additional information: describe event or problem, other relevant history, patient codes, evaluation conclusion codes.

Event Description

It was reported that the patient experienced a worsening health following implant of this inflatable penile prosthesis (ipp).Antibiotic treatment proved ineffective.The patient subsequently underwent an urgent procedure to explant the ipp due to concerns of sepsis.No additional information was reported.Additional information was received that the patient was treated starting in november 2020.In january 2021, the patient reported pain and tenderness in their scrotum with difficulty walking.The patient also experienced scrotal swelling with a purulent collection in the left hemisphere.As their condition evolved, they were later treated at a facility in germany where their device was removed without replacement.The patient was noted to be feeling well with an improved condition since removal of the device.Further information was received indicating that upon initial evaluation, a colorless secretion was found on the wound.A scrotal exporation was performed but did not identify any signs of further damage or sepsis.The patient was treated with intravenous and oral cephalosporin during their initial hospitalization and upon discharge, respectively.Later, per the patient, when they presented to clinic in germany, they were treated with an unspecified antibiotic in the form of a powder that was applied directly to the wound.Over the course of several days, symptoms of sepsis appeared including abscess, purulent discharge, and fever; the device was explanted at that time.The patient did not have any underlying medical conditions, the only potential contributing factor noted by the physician was that the patient was overweight.

Manufacturer Narrative

Investigation summary: based on the information available, the reported clinical observations cannot be confirmed.The returned product exhibited damage consistent with explant but no further anomalies were identified.The reported patient symptoms are known risks associated with inflatable penile prosthesis (ipp) devices.Device history record (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Technical analysis: upon receipt at our post market quality assurance laboratory, this ams 700 was thoroughly analyzed.The momentary squeeze (ms) pump was visually inspected and functionally tested; no leaks were found and the pump performed within specification.The cylinders were visually inspected and leak tested.A leak was found in cylinder 1 consistent with sharp instrument damage at explant; the cylinder was not pressure tested.Cylinder 2 was tested and performed within specification.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.Physical analysis of the product could not confirm the reported patient symptoms.Labeling review: the ams 700 instructions for use (ifu) was reviewed.The patient symptoms sepsis, pain, purulent discharge, swelling, abscess and fever were found to be listed in the ifu.There is no objective evidence that the user did not properly handle or use the device according to the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

Event Description

It was reported that the patient experienced a worsening health following implant of this inflatable penile prosthesis (ipp).Antibiotic treatment proved ineffective.The patient subsequently underwent an urgent procedure to explant the ipp due to concerns of sepsis.No additional information was reported.Additional information was received that the patient was treated starting in november 2020.In (b)(6) 2021, the patient reported pain and tenderness in their scrotum with difficulty walking.The patient also experienced scrotal swelling with a purulent collection in the left hemisphere.As their condition evolved, they were later treated at a facility in germany where their device was removed without replacement.The patient was noted to be feeling well with an improved condition since removal of the device.Further information was received indicating that upon initial evaluation, a colorless secretion was found on the wound.A scrotal exploration was performed but did not identify any signs of further damage or sepsis.The patient was treated with intravenous and oral cephalosporin during their initial hospitalization and upon discharge, respectively.Later, per the patient, when they presented to clinic in germany, they were treated with an unspecified antibiotic in the form of a powder that was applied directly to the wound.Over the course of several days, symptoms of sepsis appeared including abscess, purulent discharge, and fever; the device was explanted at that time.The patient did not have any underlying medical conditions, the only potential contributing factor noted by the physician was that the patient was overweight.

• 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
• MDR Report Key: 11385288
• MDR Text Key: 233754309
• Report Number: 2183959-2021-00695
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003597
• UDI-Public: 00878953003597
• Combination Product (y/n): Y
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/21/2020
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 1000125483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Date Manufacturer Received: 04/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR