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

Model Number 72403334

Device Problems Collapse (1099); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Additional product component: model number/catalog number: 72400152, serial number: null, batch/lot number 398781004, model/catalog description reservoir 65ml.

Event Description

It was reported that the patient experienced cylinder rupture resulting in fluid loss and the pump stayed collapsed with an inflatable penile prosthesis (ipp).The ipp cylinder and pump were explanted, the reservoir could not be explanted due to heavy encapsulation after duration of implant and a new ipp cylinder and pump were implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Manufacturer Narrative

Device analysis: malfunction was reported.The ams700 device was visually inspected and functionally tested.There was a leak in one cylinder due to fold wear this cylinder also and broken fabric threads.This cylinder also had a hole in the outer tube due to sharp instrument damage consistent with explant damage.The other cylinder had broken fabric threads and bulging when inflated.The pump was not functionally tested due to the cylinder failures.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause traced to component failure.This complaint investigation conclusion code is utilized for an expected or random component failure without any design or manufacturing issue.Based on the results of this investigation, no escalation is necessary.Additional product component: model number/catalog number 72400152, serial number: null, batch/lot number 398781004, model/catalog description reservoir 65ml.

Event Description

It was reported that the patient experienced cylinder rupture resulting in fluid loss and the pump stayed collapsed with an inflatable penile prosthesis (ipp).The ipp cylinder and pump were explanted, the reservoir could not be explanted due to heavy encapsulation after duration of implant and a new ipp cylinder and pump were implanted.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

• 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: 8683438
• MDR Text Key: 147478270
• Report Number: 2183959-2019-63825
• Device Sequence Number: 1
• Product Code: FHW
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2008
• Device Model Number: 72403334
• Device Catalogue Number: 72403334
• Device Lot Number: 370411006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 06/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention