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

Model Number 72401451

Device Problems Deflation Problem (1149); Inflation Problem (1310); Defective Device (2588); Migration (4003); Failure to Deflate (4060)

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

Event Date 07/04/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that four weeks post implant procedure, the physician observed asymmetry in the ambicor penile prosthesis (app).The right cylinder descended in the corpus cavernosum and did not reach the distal part of the glans, which makes inflation and deflation difficult.An ultrasound of the penis was performed and it was observed that the right cylinder has a kink in the middle of the penis; therefore, the cylinder is not reaching the distal tip of the glans.There were no patient complications reported.

Event Description

It was reported that four weeks post implant procedure, the physician observed asymmetry in the ambicor penile prosthesis (app).The right cylinder descended in the corpus cavernosum and did not reach the distal part of the glans, which makes inflation and deflation difficult.An ultrasound of the penis was performed and it was observed that the right cylinder has a kink in the middle of the penis; therefore, the cylinder is not reaching the distal tip of the glans.The patient underwent surgery in which the app was removed and replaced with a malleable prosthesis.There were no patient complications.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that four weeks post implant procedure, the physician observed asymmetry in the ambicor penile prosthesis (app).The right cylinder descended in the corpus cavernosum and did not reach the distal part of the glans, which makes inflation and deflation difficult.An ultrasound of the penis was performed and it was observed that the right cylinder has a kink in the middle of the penis; therefore, the cylinder is not reaching the distal tip of the glans.The patient underwent surgery in which the app was removed and replaced with a malleable prosthesis.There were no patient complications.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this ambicor penile prosthesis underwent a thorough analysis.The cylinders and pump were visually and microscopically examined, leak and functionally tested.No anomalies were found with the device.Based on the information available and analysis results, the reported device allegation could not be confirmed.A conclusion code of no problem detected was assigned to this investigation.

• Brand Name: AMS AMBICOR 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: 15594717
• MDR Text Key: 301775858
• Report Number: 2124215-2022-41189
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: 00878953000954
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: N970012
• 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,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2023
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 1000174348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG