MAUDE Adverse Event Report: IMPRESS®.BRAIDED; PERIPHERAL CATHETERS

Catalog Number	46538KA2
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that during a peripheral vascular interventional procedure on (b)(6) 2021, the catheter tip detached within the patient.The physician had acquired retrograde arterial access and had successfully negotiated the patient's abdominal aortic bifurcation with an.038 guidewire and guide catheter under fluoroscopy.The physician was attempting to remove the guide catheter when he felt the catheter tip detach within the patient's abdominal aortic arch.The physician successfully removed the foreign body from the patient with a vascular snare device.The patient tolerated the procedure well.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint is confirmed.The root cause could not be determined.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
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 11562426
• Report Number: 3010665433-2021-00016
• Device Sequence Number: 4183318
• Product Code: DQO
• UDI-Device Identifier: 00884450023204
• UDI-Public: 884450023204
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 46538KA2
• Device Lot Number: E1807423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: GUIDEWIRE .038; GUIDEWIRE .038
• Outcome Attributed to Adverse Event: Required Intervention