MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALTATRACK GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	884838070974
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Date of birth not available.Not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is germany.Block g2: study name - learn registry.Blocks h3 & h6: the altatrack guidewire was discarded by the facility, thus no returned product investigation was performed.Blocks h7 & h9: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that on (b)(6) 2021, an altatrack guidewire was used in a bevar procedure in the abdominal aorta plus side branches.The altatrack guidewire was used along with non-philips conventional guidewires in combination with conventional catheters.No patient injury or device malfunction was reported at the time of the procedure.However, 8 days post procedure on (b)(6) 2021, a dissection was noted in the descending aorta (celiac trunk, stenotic >50%, not calcified <50%), but no intervention was performed.This adverse event is being submitted in abundance of caution because it could not be determined if the altatrack guidewire caused or contributed to the dissection.
Additional Manufacturer Narrative
Blocks b5/g3: additional information was provided by the site on 23nov2022.Block d10: terumo guidewire was listed as a concomitant device in the initial mdr.Block f10: the hecc and heic complaint codes were updated to reflect no patient injury: hecc code 3160 (vascular dissection) was replaced with code 4582 (no clinical signs, symptoms or condition).Heic code 4164-serious injury/ illness/ impairment) was replaced with code 2199 (no health consequences or impact).Block h2: correction- this event is no longer reportable based on the additional information received.Block h6: added conclusion code 4310 (caused traced to non-device related factors).Code 67 (no problem detected) from the initial mdr remains applicable.
Event or Problem Description
This adverse event is no longer reportable for a dissection.Additional information confirmed the altatrack device did not cause the dissection.The task was completed with a terumo guidewire.

• Brand Name: ALTATRACK GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: katarzyna feliksik ; veenpluis 6; best 5684 -PC ; NL 5684 PC
• MDR Report Key: 15846300
• Report Number: 3003768277-2022-10504
• Device Sequence Number: 14947970
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)220913(10)6650341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022
• Report Date (Section F): 12/19/2022

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: 09/13/2022
• Device Model Number: 884838070974
• Device Catalogue Number: 432207013483
• Device Lot Number: 6650341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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: TERUMO: 0.035 GUIDE WIRE; UNK MFG AND SIZE: CONVENTIONAL CATHETERS; UNK MFG AND SIZE: CONVENTIONAL GUIDEWIRES; UNK MFG: 12F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 12/19/2022