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

Model Number UNK-P-IPP

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

Patient Problems Erosion (1750); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Septic Shock (2068); Cognitive Changes (2551); Swelling/ Edema (4577)

Event Date 02/12/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced swelling and pain with an inflatable penile prosthesis (ipp).The patient also suspected that the cylinders were potentially eroding distally under the glans on the left side.The patient had not seen an urologist regarding the symptoms, but asked for a referral note to a different surgeon.The physician recommended the patient avoid cycling the device to avoid adding pressure to the tissue prior to further assessment.No additional patient complications were reported and no additional information was provided.

Manufacturer Narrative

Investigation summary: based on the information available, there was no device available for analysis.The reported patient symptom is a known risk associated with ams 700 procedures and is noted as such in the device instructions for use.Dhr review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ams 700 instructions for use (ifu).The ams 700 ifu lists pain, swelling, erosion, infection, fever, hallucinations, purulent discharge, sepsis and shock, septic as potential adverse events associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient experienced swelling and pain with this inflatable penile prosthesis (ipp).The patient also suspected that the cylinders were potentially eroding on the left side, distally under the glans.The patient had not seen an urologist regarding the symptoms, but asked for a referral to a different surgeon.The physician advised the patient not to cycle the device to avoid the pressure effect on the tissue prior to the next consult.A month later, the patient had a fever with hallucinations.The front tips of the ipp were eroding and caused enough damage that there was pus present.The patient was found to be septic.The patient stated that they were still not able to contact a physician that did not recommend explant.The patient stated that they did not want the ipp removed as they were concerned it might not be able to be reinserted.The patient later entered septic shock and the device was explanted; no new device will be reimplanted for at least six months.The patient requested guidance to find an urologist because they suspect atrophy might occur in the future after not having a device for so long.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 13700410
• MDR Text Key: 286852188
• Report Number: 2124215-2022-06697
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male