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

Catalog Number	59038UAC
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The physician alleges that during a prostatic artery embolization (pae) procedure, to improve lower urinary tract symptoms.The catheter tip detached within the patient.The physician had acquired retrograde femoral artery access and had negotiated the patient's vasculature under fluoroscopy to the targeted uterine artery of interest.During catheter manipulations over a guidewire the catheter tip detached.The physician used a vascular snare device to successfully retrieve the foreign body from the patient.The patient tolerated the procedure well.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to significant force being applied to the device during use.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: PERIPHERAL CATHETERS
• MDR Report Key: 10985374
• Report Number: 3010665433-2020-00051
• Device Sequence Number: 3562253
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/25/2020

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: 08/31/2022
• Device Catalogue Number: 59038UAC
• Device Lot Number: E1654316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 04/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2019
• 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; GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention