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

Model Number 72404233-12

Device Problem Inflation Problem (1310)

Patient Problems Wound Dehiscence (1154); Pain (1994); Urinary Retention (2119); Discomfort (2330); Constipation (3274); Swelling/ Edema (4577); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced issues with initial activation at the first follow-up ((b)(6) 2020) following the implant ((b)(6) 2020) of an inflatable penile prosthesis (ipp).The ipp remains implanted and active.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported mechanical issue cannot be confirmed as the product is not available for analysis.Device history record: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could not be performed.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient experienced issues with initial activation at the first follow-up ((b)(6) 2020) following the implant ((b)(6) 2020) of an inflatable penile prosthesis (ipp).The ipp was explanted.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Event Description

It was reported that the patient experienced issues with initial activation at the first follow-up ((b)(6) 2020) following the implant ((b)(6) 2020) of an inflatable penile prosthesis (ipp).On 16oct2020 the patient returned for an additional follow-up and was experiencing pain, discomfort, and the inability to pass urine; the physician was also able to cycle the device without any issue.On (b)(6) 2021 the ipp pump was explanted and replaced.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the reported allegation of pump activation difficulty was confirmed through analysis.The device instructions for use (ifu) describe various scenarios which can result in the symptoms of pain, discomfort, swelling, and constipation observed clinically.The patient device experience is included in the labeling and is, therefore, anticipated in nature.Technical analysis: the product was returned for analysis to our post market quality assurance laboratory.Visual examination and and functional testing was conducted.The pump did not pass deflation testing; there was unwanted fluid in the pump flowing across the valve when the pump was being pumped to and from the reservoir.This could have resulted in the reported pump activation difficulties.Labeling review: a review of the ifu was completed and identified the reported event related to pain, discomfort, swelling, constipation is anticipated in nature and severity is discussed in the pump ifu.The reported events also do not contain an allegation against the labeling.Device history record (dhr) review: dhr review confirmed that the device met all material, assembly and performance specifications.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that the patient experienced issues with initial activation at the first follow-up approximately one month after the implant of this inflatable penile prosthesis (ipp).Two months later, the patient returned for an additional follow-up as they were experiencing pain in their abdomen near the reservoir, discomfort, swelling, and constipation.The physician was also able to cycle the device without any issue.The patient also believes the length of their penis has been reduced.The pump was explanted and replaced.No additional patient complications were reported.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes that the reported allegation of pump activation difficulty was confirmed through analysis.The device instructions for use (ifu) describe various scenarios which can result in the symptoms of pain, discomfort, swelling, and constipation observed clinically.The patient device experience is included in the labeling and is, therefore, anticipated in nature.Technical analysis: the product was returned for analysis to our post market quality assurance laboratory.Visual examination and and functional testing was conducted.The pump did not pass deflation testing; there was unwanted fluid in the pump flowing across the valve when the pump was being pumped to and from the reservoir.This could have resulted in the reported pump activation difficulties.Labeling review: a review of the ifu was completed and identified the reported event related to pain, discomfort, swelling, constipation is anticipated in nature and severity is discussed in the pump ifu.The reported events also do not contain an allegation against the labeling.Device history record (dhr) review: dhr review confirmed that the device met all material, assembly and performance specifications.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that during a follow-up on 14aug2020, the patient presented with some pain in the abdomen in the area of the reservoir as well as some swelling.The patient was not taking any medications to treat the pain.The patient was also experiencing constipation.On (b)(6) 2020, the patient had another follow-up, presenting with dehiscence without signs of drainage at the incision site.It was noted that the patient was healing with the cylinders in place and the pump in a good position.The patient still had pain when going from sitting to standing.On (b)(6) 2020, the patient attended another follow-up and reported that the pain and swelling had resolved.The patient was experiencing difficulties inflating the device; during examination of the device the physician was able to successfully cycle the device with the observation that the pump kept locking out.During follow-up on (b)(6) 2020, the patient was still experiencing difficulties inflating the device, but was occasionally able to activate the device.The patient is also reporting the device has reduced the length of the penis.The physician was able to cycle the device successfully and advised the patient that he had maximized the patients implant.The physician advised the patient to cycle the device daily.On (b)(6) 2021, the patient underwent a surgical procedure to remove and replace the pump.During a follow-up on (b)(6) 2021, the patient reported mild scrotal edema around the pump and a small dehiscence at the incision site without any other symptoms.The patient was prescribed augmentin and was instructed to elevate the scrotum and apply heat to the scrotum while resting.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13110416
• MDR Text Key: 282909590
• Report Number: 2124215-2021-38987
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• 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,Followup,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2020
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1000096941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male