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

Model Number 72404310

Device Problems Failure to Cycle (1142); Mechanical Problem (1384); Connection Problem (2900)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.

Event Description

It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that there was a minor abrasion causing the connector had worn down, and the patient had some discomfort when the patient attempted to cycle the device.

Manufacturer Narrative

Device analysis: a connector disorder was reported.There were three window quick connectors (wqc) returned attached to the ms pump tubing.The wqc's were visually inspected.All three wqc performed within specifications.A ms pump was also returned.The ams700 momentary squeeze pump was visually inspected.No leak was found.The pump was not functionally tested due to contamination.The allegation of connector disorder was not confirmed.Based on the results of this investigation, no escalation is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.

Manufacturer Narrative

Additional information:b5.

Event Description

It was reported that the patient experienced connector disorder with an inflatable penile prosthesis (ipp).The ipp pump was explanted and a new ipp pump was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that there was a minor abrasion causing the connector had worn down, and the patient had some discomfort when the patient attempted to cycle the device.

• 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: 8865368
• MDR Text Key: 153410739
• Report Number: 2183959-2019-65523
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2021
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 122712002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 10/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR