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

Model Number 72404231

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported that the implanted inflatable penile prosthesis (ipp) was functional, but the sizing was not correct, it was too short.The patient had hypermobile glans.A revision surgery was performed.The cylinders and pump were replaced only.The old reservoir retained; new reservoir was implanted.The surgeon felt the option to keep the old reservoir implanted was safer than explanting it.There were no further patient complications.

Event Description

It was reported that the implanted inflatable penile prosthesis (ipp) was functional, but the sizing was not correct, it was too short.The patient had hypermobile glans.A revision surgery was performed.The cylinders and pump were replaced only.The old reservoir retained; new reservoir was implanted.The surgeon felt the option to keep the old reservoir implanted was safer than explanting it.There were no further patient complications.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported event could not be confirmed.Based on the analysis results, an investigation conclusion code of unintended use error caused or contributed to event was assigned to this investigation as incorrect size of the device may have caused the reported event.

Manufacturer Narrative

D4.Model number, lot number, catalog number, expiration date and unique identifier (udi) # updated d10.Concomitant product/therapy updated h4.Device manufacture date updated h6.Evaluation method codes, evaluation result codes and evaluation conclusion codes updated.

Event Description

It was reported that the implanted inflatable penile prosthesis (ipp) was functional, but the sizing was not correct, it was too short.The patient had hypermobile glans.A revision surgery was performed.The cylinders and pump were replaced only.The old reservoir retained; new reservoir was implanted.The surgeon felt the option to keep the old reservoir implanted was safer than explanting it.There were no further patient complications.

Event Description

It was reported that the implanted inflatable penile prosthesis (ipp) was functional, but the sizing was not correct, it was too short.The patient had hypermobile glans.A revision surgery was performed.The cylinders and pump were replaced only.The old reservoir retained; new reservoir was implanted.The surgeon felt the option to keep the old reservoir implanted was safer than explanting it.There were no further patient complications.

Manufacturer Narrative

Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.The cylinders and momentary squeeze (ms) pump were visually examined and functionally tested for leaks.Both cylinders had wear at a fold in the middle of the cylinders.Both cylinders passed the leak test.The ms pump was visually inspected, leak tested, and functionally tested.Ms pump passed visual inspection and there were no visual damages or anomalies found.Ms pump passed the leak test.Ms pump did not pass activation tests.Product analysis was unable to confirm the reported allegation.Based on the analysis results, an investigation conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18016945
• MDR Text Key: 326674742
• Report Number: 2124215-2023-59860
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/24/2022
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 1000402594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• 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
• Treatment: REAR TIP EXTENDER: 72404326/1000244403.; REAR TIP EXTENDER: 72404326/1000244403.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR