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

Model Number 72401850

Device Problem Malposition of Device (2616)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgical procedure.After two days, the physician communicated that the reservoir was inside the bladder.A new surgical procedure was performed and the ipp was removed and replaced with a malleable device; also, a drain and a suprapubic catheter were placed.There were no additional patient complications reported.

Manufacturer Narrative

B5: describe event or problem and h6: patient codes were updated.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgical procedure.After two days, the physician communicated that the reservoir perforated the bladder and it was inside of it with presence of blood.A new surgical procedure was performed and the ipp was removed and replaced with a malleable device; also, a drain and a suprapubic catheter were placed.There were no additional patient complications reported.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) surgical procedure.After two days, the physician communicated that the reservoir perforated the bladder and it was inside of it with presence of blood.A new surgical procedure was performed and the ipp was removed and replaced with a malleable device; also, a drain and a suprapubic catheter was placed.There were no additional patient complications reported.

Manufacturer Narrative

The complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device was unable to be performed as the lot numbers were unknown.The clinical observations of perforation and hemorrhage could not be confirmed.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS ACCESSORY KIT
• 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
• MDR Report Key: 14781116
• MDR Text Key: 294575274
• Report Number: 2124215-2022-22320
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• 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
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72401850
• Device Catalogue Number: 72401850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Black Or African American