MAUDE Adverse Event Report: CLINICAL INNOVATIONS LLC. INTRAUTERINE PRESSURE CATHETER; TRANSDUCER, PRESSURE, INTRAUTERINE

Model Number IPC-5000E

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

The catheter would not release from the introducer.Once it was removed from the patient, the physician was able to force the catheter from the introducer, but with more force than would normally be needed.Another catheter was obtained and inserted without difficulty.No harm to patient.Fda safety report id# (b)(4).

• Brand Name: INTRAUTERINE PRESSURE CATHETER
• Type of Device: TRANSDUCER, PRESSURE, INTRAUTERINE
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC.; murray UT 84123
• MDR Report Key: 13059622
• MDR Text Key: 282772212
• Report Number: MW5106181
• Device Sequence Number: 1
• Product Code: HFN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPC-5000E
• Device Lot Number: 214676 & 214729
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White