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

Model Number 72404209

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem Scarring (2061)

Event Date 03/17/2020

Event Type  Injury  

Event Description

It was reported that the inflatable penile prosthesis (ipp) pump was not working consistently.The "surgeon reports that ms pump which was replaced in (b)(6) 2020 is still not working consistently.At the time of implantation the pump was working as would be expected.Surgeon states that the deflate button seems to be partially depressed at all times, and is not as easy to palpate as usual.Surgeons wonders if patient scarring as he heals may be influencing position of deflate button.Surgeon reports that he may carefully inject some steroid to aid scarring formation.Patient has been encouraged to remain calm and patient." additional information received states no further interventions or treatments have been performed and that the pump issues have not resolved.

Event Description

It was reported that the inflatable penile prosthesis (ipp) pump was not working consistently.The "surgeon reports that ms pump which was replaced in (b)(6) 2020 is still not working consistently.At the time of implantation the pump was working as would be expected.Surgeon states that the deflate button seems to be partially depressed at all times, and is not as easy to palpate as usual." despite the surgeon trying troubleshooting several times, the pump remains flat, hard and unable to move fluid into the cylinders."surgeons wonders if patient scarring as he heals may be influencing position of deflate button.Surgeon reports that he may carefully inject some steroid to aid scarring formation.Patient has been encouraged to remain calm and patient." the patient has been booked for an exploration/revision surgery with the intent of seeing if the pump can be worked successfully while the patient is under general anesthesia.If not, a replacement pump will be inserted on (b)(6) 2020.Prior to bringing the patient back for additional surgery the surgeon decided to further trouble-shoot the device.He focused on forced deflation and resetting the lockout valve.He reported that none of the techniques tired worked although he was able to inflate the cylinders slightly.Ultimately he is stating that either the pump would not inflate at all, being evidenced by no fluid moving into the cylinders, or if inflation happened the cylinders would not hold any fluid and would drain out the cylinders spontaneously.

Event Description

It was reported that the inflatable penile prosthesis (ipp) pump was not working consistently.The "surgeon reports that ms pump which was replaced in (b)(6) 2020 is still not working consistently.At the time of implantation the pump was working as would be expected.Surgeon states that the deflate button seems to be partially depressed at all times, and is not as easy to palpate as usual." despite the surgeon trying troubleshooting several times, the pump remains flat, hard and unable to move fluid into the cylinders."surgeons wonders if patient scarring as he heals may be influencing position of deflate button.Surgeon reports that he may carefully inject some steroid to aid scarring formation.Patient has been encouraged to remain calm and patient." the patient has been booked for an exploration/revision surgery with the intent of seeing if the pump can be worked successfully while the patient is under general anesthesia.If not, a replacement pump will be inserted on (b)(6) 2020.Prior to bringing the patient back for additional surgery the surgeon decided to further trouble-shoot the device.He focused on forced deflation and resetting the lockout valve.He reported that none of the techniques tried worked although he was able to inflate the cylinders slightly.Ultimately he is stating that either the pump would not inflate at all, being evidenced by no fluid moving into the cylinders, or if inflation happened the cylinders would not hold any fluid and would drain out the cylinders spontaneously.The ipp pump was later replaced on (b)(6) 2020.

Manufacturer Narrative

Device evaluation: allegation related to pump collapse and mechanical issue were reported.The ams 700 momentary squeeze (ms) pump was visually inspected.The contamination was found inside the pump.The pump was not functionally tested due to contamination.Product analysis was unable to confirm the reported events, nor a device malfunction related to the allegations.The product record review indicated 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 the reported events could not be confirmed nor substantiated through investigation of the pump.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9944426
• MDR Text Key: 188389222
• Report Number: 2183959-2020-01952
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003351
• UDI-Public: 00878953003351
• 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,Followup
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2021
• Device Model Number: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 1000330153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 07/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR