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

Model Number 72404310

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  Injury  

Event Description

It was reported that the patient had a surgical procedure to replace an inflatable penile prosthesis(ipp) device due to a crack in the connection tube causing a leak.A patient outcome of stable was reported.

Event Description

It was reported that the patient had a surgical procedure to replace an inflatable penile prosthesis(ipp) device due to a crack in the connection tube causing a leak.A patient outcome of stable was reported.

Manufacturer Narrative

Investigation summary: the device was returned for analysis.Product analysis was unable to confirm the reported event.Device history record (dhr) : the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis the ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The tubing was identified to be cut down to the pump block.The tubing was not returned for analysis.The contamination was found inside pump.The pump was not functionally tested due to contamination.Product analysis was unable to confirm the reported event.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ifu, ams700 ms pump.Additionally, the reported events do not contain an allegation against the labeling.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11240960
• MDR Text Key: 229084708
• Report Number: 2183959-2021-00180
• 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,o
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/27/2022
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 0167601001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR