MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 53035KA2

Device Problems Material Rupture (1546); Material Separation (1562)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a peripheral vascular procedure, the catheter tip detached outside the patient.The physician had successfully acquired retrograde arterial access, and the catheter was introduced over a stiff guidewire, the lesion was crossed, and contrast was injected to collect selective angiograms.The catheter was removed from the patient and placed back on the sterile field.At a later point within the procedure, the clinician decided to use the 5f ka2 catheter again.When an attempt was made to reload the catheter over the back end of the guidewire, the tip detached and was dangling from the catheter shaft.A new catheter was opened and used to complete the procedure.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11813233
• MDR Text Key: 250238231
• Report Number: 3010665433-2021-00027
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450032565
• UDI-Public: 884450032565
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Catalogue Number: 53035KA2
• Device Lot Number: E2065224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LAURATE STIFF GUIDEWIRE.; LAURATE STIFF GUIDEWIRE