MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION

Model Number UNK-D-PELVIC HEALTH

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a replacement surgery in which an inflatable penile prosthesis (ipp) was implanted because the left cylinder of the explanted device was broken down and caused a fluid leak in system.The model of the device explanted was not specified.The patient made a full recovery with a functional device.

Manufacturer Narrative

Investigation summary: based on the information available, boston scientific concludes that the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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.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 perforation as a potential adverse event associated with implant of this device.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 underwent a replacement surgery in which an inflatable penile prosthesis (ipp) was implanted because the left cylinder of the explanted device was broken down and caused a fluid leak in system.The model of the device explanted was not specified.The patient made a full recovery with a functional device.

• 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: 12746225
• MDR Text Key: 279891457
• Report Number: 2124215-2021-34119
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-D-PELVIC HEALTH
• Device Catalogue Number: UNK-D-PELVIC HEALTH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• 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; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male