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

Catalog Number	565352RC
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
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.
Event or Problem Description
The account alleges that during a uterine artery embolization [uae] procedure, the catheter tip detached within the patient.The physician had acquired retrograde arterial access and during catheter manipulations under fluoroscopy, over a guide wire the catheter tip detached.The physician successfully retrieved the foreign body from the patient.The patient tolerated the procedure well and was discharged to home with no additional consequences to report.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 11020459
• Report Number: 3010665433-2020-00060
• Device Sequence Number: 19504241
• Product Code: DQO
• UDI-Device Identifier: 00884450009376
• UDI-Public: 884450009376
• 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
• Report Date (Section B): 11/26/2020

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 565352RC
• Device Lot Number: E1419507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/16/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2018
• 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: GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention