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

Model Number	ATG35120A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a peripheral therapeutic t-branch endovascular aortic repairment procedure, an altatrack guidewire was used with a non-philips angiographic catheter.This did not work sufficiently as the aimed vessel depth could not be attained, and a proper and safe positioning of the catheter could not be established because the celiac artery trunk was very tortuous and highly calcified.The altatrack guidewire visualization was intermittently interrupted due to bend radius errors causing the guidewire tip to hit anatomical structures and lose signal.This required frequent intervals to check the guidewire placement under fluoroscopy.The altatrack guidewire was exchanged to a conventional hydrophilic angled guidewire (terumo) to establish a stable position.This maneuver was cumbersome, but successful.The remainder of the procedure was completed without any further support from fors technology due to the highly calcified anatomies of the target vessels.After the procedure was completed, the patient was transferred to the intensive care unit (icu), but the patient's condition worsened shortly after.An x-ray was performed and two hematomas were found; iliac artery (not related to altatrack) and left gastric artery, side branch of the celiac artery trunk.A perforation was identified in the left gastric artery and was treated successfully with coil embolization in a second emergency procedure on the same day.Additionally, the patient required about 13 units of red cell concentrates and extensive icu stay.Per the physician, both used guidewires (altatrack & terumo) slipped deeply into the left gastric artery and may have caused the vessel rupture, which remained undiscovered during the t-branch endovascular aortic repairment procedure.The altatrack guidewire did not show any visible signs of a damage after it was pulled for the exchange to the terumo guidewire.This adverse event is being submitted because the altatrack guidewire likely caused the perforation, and required additional intervention.There was no alleged malfunction with the altatrack guidewire.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks e1 & g2: country is germany.Blocks h3: the altatrack guidewire was discarded and not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Block h6: no device or use related root cause has been identified.Perforations during this kind of procedure are a known side effect and are covered by the device risk management.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.

• 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: priscilla chai ; veenpluis 6; best 5684 -PC ; NL 5684 PC ; 31643215596
• MDR Report Key: 18041697
• Report Number: 3003768277-2023-10507
• Device Sequence Number: 15517646
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)240718(10)8212847
• 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): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2023
• Report Date (Section F): 10/31/2023

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: 07/18/2024
• Device Model Number: ATG35120A
• Device Catalogue Number: ATG35120A
• Device Lot Number: 8212847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: COOK MEDICAL: 22F ZENITH T-BRANCH INTRO SHEATH; TERUMO: COBRA 5F ANGIOGRAPHIC CATHETER; TERUMO: GLIDEWIRE .035 GUIDEWIRE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/31/2023