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

Catalog Number	53035KA2
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11813233
• Report Number: 3010665433-2021-00027
• Device Sequence Number: 3766578
• Product Code: DQO
• UDI-Device Identifier: 00884450032565
• UDI-Public: 884450032565
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAURATE STIFF GUIDEWIRE.; LAURATE STIFF GUIDEWIRE