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 Problem Internal Organ Perforation (1987)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported that during an inflatable penile prosthesis (ipp) implant operation the patient had a bladder perforation.A catheter was placed and a tactra was implanted as a place holder to treat the perforation.On a follow up procedure, a revision surgery was performed to replace the tactra to inflatable penile prosthesis (ipp) because the patient wanted a three-piece device that would be more concealable.No further patient complications were reported.

Event Description

It was reported that, during implant of this inflatable penile prosthesis (ipp), the bladder was perforated.A catheter was placed and a tactra was implanted as a place holder to treat the perforation.Subsequently, a revision surgery was performed to replace the tactra to an inflatable penile prosthesis (ipp); the patient wanted a three-piece device that would be more concealable.No further patient complications were reported.

Manufacturer Narrative

[yesterday 9:36 pm] carver, gwynn (she/her/hers).There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of perforation is a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16522726
• MDR Text Key: 311073476
• Report Number: 2124215-2023-11151
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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: 03/15/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male