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	11/19/2020
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 account alleges that during a uterine artery embolization [uae] procedure the 5f catheter fragmented within the patient.The physician had successfully acquired retrograde arterial access.During catheter manipulations over a guidewire under fluoroscopy, the catheter tip detached within the superior mesenteric artery (sma).The physician noted, the patient's anatomy was not tortuous, calcified, or diseased.The tip detachment was not considered life threatening.All but one small piece of the foreign body was successfully retrieved from the patient via vascular snare device.To avoid possible migration of the remaining foreign body, the physician deployed a stent to pin the foreign body in place.The patient tolerated the procedure well with no other injuries to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A photograph was provided by the account.The complaint is confirmed.The root cause could not be determined however, the fragmented tip has the appearance to have been stored in 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.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: IMPRESS®.BRAIDED. CATHETER
• Common Device Name: DIAGNOSTIC CATHETER UAC
• MDR Report Key: 10938745
• Report Number: 3010665433-2020-00049
• Device Sequence Number: 3234703
• 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): 11/20/2020

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: E1570331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 03/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention