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

Catalog Number	56538CB2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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 an embolization/spinal angiogram procedure that originated on (b)(6) 2021, for a spinal cord arteriovenous malformation (avm), a catheter tip detached in several pieces within the patient.The physician successfully acquired right retrograde femoral artery access with a 6f sheath and had successfully negotiated the patient iliac bifurcation to successfully cannulate the ostium of a intercostal artery to opacify spinal avm vessels under fluoroscopy with a 5f cb2 catheter.During catheter manipulations within the intercostal artery, the catheter detached into three pieces in-vivo and migrated toward the patient's periphery.Secondary bilateral vascular access was acquired via the left retrograde femoral artery with a 9f sheath in an attempt to retrieve the foreign bodies located within an intercostal artery when the foreign body once again detached within the patient.The physician stopped the procedure and started 3000 u of heparin.Ultrasonography imaging was ordered for the lower extremities including the renal arteries.Additional observation time was extended 48 hours for the lower extremities.The catheter was then removed from the patient and detached yet again outside the patient body.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause could not be determined.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
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 11787859
• Report Number: 3010665433-2021-00025
• Device Sequence Number: 3634461
• Product Code: DQO
• UDI-Device Identifier: 00884450035955
• UDI-Public: 884450035955
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 04/12/2021

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: 12/31/2021
• Device Catalogue Number: 56538CB2
• Device Lot Number: E1504915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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: ACCESS SHEATHS [6F, 9F]; INTERVENTIONAL GUIDEWIRE
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention