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

Model Number UNK-P-IPP

Device Problems Collapse (1099); Deflation Problem (1149); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  Injury  

Event Description

It was reported that patient underwent a replacement surgery of his inflatable penile prosthesis (ipp) due to pump was not working nor deflating properly.Pump and cylinders were explanted and they left the reservoir implanted.A new preconnect was implanted.No information as of the patient outcome (surgery is still ongoing onset of the call).Rep do not have the lot/upn of the explanted item.Explanted device is available for returned.Additional information was received.Patient could not inflate the device.Pump would stay flat.Physician could not inflate it either.No adverse patient effects.

Event Description

It was reported that patient underwent a replacement surgery of his inflatable penile prosthesis (ipp) due to pump was not working nor deflating properly.Pump and cylinders were explanted and they left the reservoir implanted.A new pre connect was implanted.No information as of the patient outcome (surgery is still ongoing onset of the call).Rep do not have the lot/upn of the explanted item.Explanted device is available for returned.Additional information was received.Patient could not inflate the device.Pump would stay flat.Physician could not inflate it either.No adverse patient effects.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.Based on the results of this investigation, no escalation is required.

• 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: 9260183
• MDR Text Key: 164432318
• Report Number: 2183959-2019-67213
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR