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 Code	Vascular Dissection (3160)
Date of Event	12/17/2021
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.Implant & explant date: not applicable for this device.Report source: study name - learn registry.The altatrack guidewire was not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Recall: (if recall number is given) & correction/removal rpt number: (recall numbers:): 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 during a peripheral therapeutic procedure, a altatrack berenstein catheter was loaded over an altatrack guidewire.While cannulating in the left renal artery, a dissection occurred.The lesion was wired with an 0.014" non-manufacturer's's support wire and covered with a stent.There was no device malfunction reported.This adverse event is being submitted because a dissection occurred and required stent placement.
Additional Manufacturer Narrative
Block b5: the second dissection was found during periodic review of the learn registry database.
Event or Problem Description
Additional information received on 16nov2022: a second dissection covered by a stent was noted in the left renal artery accessory, related to the same altatrack device from the initial report.

• 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: 15677316
• Report Number: 3003768277-2022-10502
• Device Sequence Number: 6421760
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)220506(10)6418856
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022
• Report Date (Section F): 12/14/2022

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: 05/06/2022
• Device Model Number: 884838070974
• Device Catalogue Number: 432207013481
• Device Lot Number: 6418856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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: MEDTRONIC: TOURGUIDE INTRODUCER SHEATH, SIZE UNK; PHILIPS: ALTATRACK 5.5F BRN CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 12/14/2022