MAUDE Adverse Event Report: IMPRESS®.BRAIDED CATHETER; DIAGNOSTIC CATHETER UAC

Catalog Number	59038UAC
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not 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 account alleges that during an emergent uterine artery embolization [uae] procedure for post-partum hemorrhaging, the 5f catheter fragmented within the (b)(6)-year-old female patient.The patient expired 3 hours post uae procedure.The physician had successfully acquired retrograde femoral artery access.During catheter manipulations over a guidewire, under fluoroscopy at the patient's aortic bifurcation, the catheter tip detached.The physician noted, the patient's anatomy was not tortuous, calcified, or diseased.The physician attempted to retrieve the detached foreign body with a vascular snare device when the foreign body fragmented again increasing the interventional procedure time and delaying the emergent uae procedure.All foreign body fragments were successfully removed from the abdominal aorta, right external iliac, and common femoral arteries.[pictures attached in an e-mail] post-procedure: the patient was admitted to a recovery unit.The account alleges that the cause of death was unrelated to the catheter detachment however, the emergent uae was delayed due to the foreign body retrieval interventions.The patient had expired three hours later post-procedure on (b)(6) 2020." the device is not expected to return for investigation.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.Fluoroscopy images provided by the account demonstrate that the complaint is confirmed.The root cause cannot be determined however, the fragmented pieces appear to be jagged and inconsistent in sizing.The fragmented tip pieces may have been stored under extreme environmental conditions or potentially exposed to a chemical agent.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®.BRAIDED CATHETER
• Common Device Name: DIAGNOSTIC CATHETER UAC
• MDR Report Key: 10938665
• Report Number: 3010665433-2020-00050
• Device Sequence Number: 3234702
• Product Code: DQO
• UDI-Device Identifier: 00884450109373
• UDI-Public: 884450109373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/23/2020

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: 04/30/2022
• Device Catalogue Number: 59038UAC
• Device Lot Number: E1505404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 04/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2019
• 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: Death; Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 23 YR