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

Model Number 72404310

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Date 06/28/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced fluid loss due to pump connector disorder with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was 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: fluid loss was reported.The ams700 momentary squeeze pump was visually inspected.The pump was not functionally tested due to contamination.No leak was found.One straight window quick connector (wqc) was returned.One end of the connector has a collet and kink resistant tubing (krt) inserted.The other end of the connector does have a collet but no krt inserted.Fluid loss was not confirmed.

Event Description

It was reported that the patient experienced fluid loss due to pump connector disorder with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was 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: fluid loss was reported.The ams700 momentary squeeze pump was visually inspected.The pump was not functionally tested due to contamination.No leak was found.One straight window quick connector (wqc) was returned.One end of the connector has a collet and kink resistant tubing (krt) inserted.The other end of the connector does have a collet but no krt inserted.Fluid loss was not confirmed.

Event Description

It was reported that the patient experienced fluid loss due to pump connector disorder with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was 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: 8982731
• MDR Text Key: 157138172
• Report Number: 2183959-2019-66090
• 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,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2022
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0161845003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 11/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR