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

Catalog Number	410038BER-H
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
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.
Event or Problem Description
The account alleges that during a peripheral vascular interventional procedure, a diagnostic catheter tip detached within the patient.The physician had acquired retrograde arterial access and had negotiated the patient's iliac bifurcation under fluoroscopy over a guidewire with the 4f catheter.During catheter manipulations within the patient's tibial artery, the catheter tip detached.The physician successfully used a vascular snare device to retrieve the foreign body from the patient.The patient tolerated the procedure well with no additional consequences to the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.A search of the complaint database found no similar complaints for this lot number from the same customer.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: 11972056
• Report Number: 3010665433-2021-00037
• Device Sequence Number: 1060149
• Product Code: DQO
• UDI-Device Identifier: 00884450042366
• UDI-Public: 884450042366
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K093004
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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 Expiration Date: 02/06/2023
• Device Catalogue Number: 410038BER-H
• Device Lot Number: E1776004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention