MAUDE Adverse Event Report: ALTATRACK CATHETER BERENSTEIN; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	884838070950
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a peripheral fevar procedure in the abdominal aorta and side branches, the altatrack guidewire (mdr #3003768277-2021-00002) and altatrack catheter were used in the right renal artery.After navigation to the right renal artery with a steerable sheath, the physician felt resistance and angiography showed a dissection of the right renal artery.The dissection was treated by placing a longer covered stent than initially planned inside the right renal artery.The patient encountered no hemodynamic instability.The procedure was completed with the suspect device.After the procedure, the physician and the surgeon involved reviewed the angiogram and thought the dissection might have been caused by the tip of the guidewire during catheterization of the target vessel or might have been caused by the blunt tip of the catheter.This adverse event is being submitted because the altatrack catheter and altatrack guidewire were used when the patient experienced a dissection requiring additional intervention.
Additional Manufacturer Narrative
Blocks d9 & g3: the altatrack catheter berenstein was returned and evaluated by the manufacturer.Blocks h3 & h6: the altatrack catheter berenstein was visually inspected using a light microscope.No damage was observed on the catheter.
Event or Problem Description
It was reported that during a peripheral fevar procedure in the abdominal aorta and side branches, the altatrack guidewire (mdr #3003768277-2021-10502) and altatrack catheter (mdr #3003768277-2021-10501) were used in the right renal artery.After navigation to the right renal artery with a steerable sheath, the physician felt resistance and angiography showed a dissection of the right renal artery.The dissection was treated by placing a longer covered stent than initially planned inside the right renal artery.The patient encountered no hemodynamic instability.The procedure was completed with the suspect device.After the procedure, the physician and the surgeon involved reviewed the angiogram and thought the dissection might have been caused by the tip of the guidewire during catheterization of the target vessel or might have been caused by the blunt tip of the catheter.

• Brand Name: ALTATRACK CATHETER BERENSTEIN
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12249516
• Report Number: 3003768277-2021-10501
• Device Sequence Number: 4664235
• Product Code: DQO
• UDI-Device Identifier: 00884838070950
• UDI-Public: (01)00884838070950(17)220317(10)6335938
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2021
• Report Date (Section F): 07/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: 884838070950
• Device Catalogue Number: 432207013471
• Device Lot Number: 6335938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/06/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/06/2021; 09/22/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 07/30/2021; 09/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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: OSCOR: 7F DESTINO INTRODUCER SHEATH; PHILIPS: 0.035" ALTATRACK GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 86
• Date Report Sent to FDA: 07/30/2021