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

Model Number 72404012

Device Problems Mechanical Problem (1384); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  Injury  

Event Description

It was reported that the patient visited the hospital two weeks before surgery due to his inflatable penile prosthesis (ipp) was not working properly.Inspection confirmed that the left cylinder had a tear that caused a saline leak, therefore, the left cylinder was replaced.The cause of the left cylinder tear has not been elucidated in detail in the hospital.The patient had a good outcome following the procedure.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.The ams700 ipp cylinder was visually inspected.The cylinder body was identified to be cut in half that was the result of sharp instrument damage consistent with explant damage.Due to this damage being consistent with explant it will be considered a secondary failure.Product analysis was unable to confirm the reported event as sharp instrument damage was identified.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.Based on this investigation, the investigation conclusion code of cause not established was chosen because cylinder was identified to damaged cut in half, as sharp instrument damage was identified, and it will be considered a secondary failure.However, the most probable cause could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that the patient visited the hospital two weeks before surgery due to his inflatable penile prosthesis (ipp) was not working properly.Inspection confirmed that the left cylinder had a tear that caused a saline leak, therefore, the left cylinder was replaced.The cause of the left cylinder tear has not been elucidated in detail in the hospital.The patient had a good outcome following the procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11236813
• MDR Text Key: 228890506
• Report Number: 2183959-2021-00172
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953002699
• UDI-Public: 00878953002699
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/04/2017
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 804233003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR