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

Catalog Number	4653510UBF-NB
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 within the patient.The physician had successfully acquired retrograde arterial access and while removing the catheter from the patient the blacktip detached yet remained on the guidewire.The detached tip was successfully removed together with the guidewire from the patient with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device returned for evaluation.A physical evaluation of the device was conducted.The tip was then viewed under magnification.The device was received with the tip detached.The complaint is confirmed.It was noted that there was an approximate 2mm section of the tip that appears necked down due to elongation.The elongated section of tip looked to have an acceptable bond that is still intact.The root cause could not be determined however, due to the elongation noted on the returned catheter, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: IMPRESS®.NON-BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10896523
• Report Number: 3010665433-2020-00046
• Device Sequence Number: 16973103
• Product Code: DQO
• UDI-Device Identifier: 00884450026519
• UDI-Public: 884450026519
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 07/31/2022
• Device Catalogue Number: 4653510UBF-NB
• Device Lot Number: E1649772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 03/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• 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: GUIDEWIRE