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

Model Number 72404310

Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/03/2020

Event Type  Injury  

Event Description

It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) explanted.It was further explained that the pump remained flat when the bulb was pressed during a test that was performed in the doctor's office two weeks before this surgery.The patient is stable following this surgery.

Manufacturer Narrative

Correction g5: combination product.Allegation related to pump collapse was reported.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functional tested and failed deflation test (3) and activation test.The pump failed deflation test (3).The pump was unable to move fluid from cylinder side of the pump to the reservoir side of the pump when the deflation button is not pressed with 4 psi back pressure on the cylinder.The pump was failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis confirmed the reported events.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 traced to component failure' was chosen because the reported events could be traced to a component failure.Based on the results of this investigation, no escalation is required.This conclusion is supported by the following objective evidence: dhr review / similar complaint review review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Additionally, potential emerging trends are captured as part of the post market signal evaluation and escalation process.Risk review the ams 700 hazard analysis indicates that the as reported events of this complaint do not represent a new hazardous situation.Additionally, boston scientific does not have responsibility to provide training to medical professional as documented in the dfu/ifu, and the ams 700 is not a new product because it is not within the first six months of its release in any geography, and it is not a new design platform.No further review is required.

Event Description

It was reported that due to a dimpled pump causing the cylinders not to expand, the patient had his inflatable penile prosthesis (ipp) explanted.The patient was originally given directions on how to properly use his device, and it was explained that the pump remained flat when the bulb was pressed rendering the patient unable to use the device.During a test that was performed in the doctor's office two weeks before this surgery, the physician also was unable to get the device to work properly.The patient is stable following this surgery.Pump was returned for analysis.The pump was visually inspected; no leaks were found.The pump was functional tested and failed deflation test (3) and the 8lb activation test.Product analysis confirmed the reported events.

• 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: 10457326
• MDR Text Key: 204518922
• Report Number: 2183959-2020-03775
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0183420001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 165577009; 165577009; 178956010; 178956010
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR