MAUDE Adverse Event Report: Q'apel Medical Inc. Zebra; Catheter, Percutaneous

Model Number	FG 02845-02
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On july 13, 2026, q'apel medical became aware of a reported device malfunction involving a q'apel medical zebra neurovascular access catheter, 6f x 105 cm (ref ac6074-105, lot fg260401b-01), that occurred on (b)(6) 2026 during a left middle meningeal artery (mma) embolization procedure at (b)(6) hospital.Per the site report, the procedure was converted from a right radial to a femoral approach due to tortuous anatomy.While advancing a microcatheter through the subject catheter, resistance was encountered.The physician removed the subject catheter and the catheter was noted to have separated into two pieces during this removal.No additional retrieval device or intervention was required; both separated components were removed from the patient without difficulty.A replacement catheter was used and the procedure was completed without further complication.The site reported no patient injury or adverse clinical outcome; the only reported impact was a prolonged procedure.Returned product analysis identified two separated catheter shaft segments: a proximal segment measuring approximately 31 cm and a distal segment measuring approximately 80.5 cm (combined approximately 111.5 cm, approximately 6.5 cm / 6% longer than the nominal 105 cm working length).Findings included multiple kinks, flattening, and localized denting on both segments; a discrete area of reinforcement disruption/fracture and localized discoloration of undetermined origin adjacent to a kink on the proximal segment; and elongation with progressive widening of the laser-cut reinforcement tube's cut pattern over approximately 15 cm of the distal segment.The two separated ends exhibited differing separation morphology.The distal tip was not present among the returned components.The mechanism, timing, and sequence of the observed deformation and separation could not be determined from the returned product evidence alone.The manufacturer has requested follow-up from the reporting site to clarify the procedural and device-handling sequence, the timing of the separation, and the disposition of the distal tip, which was not present among the returned components despite the site's earlier statement that all catheter components were removed from the patient.This information has not yet been obtained.Accordingly, the disposition of the distal tip cannot be confirmed based on the information currently available to the manufacturer.A supplemental report will be submitted if additional relevant information is obtained.

• Brand Name: Zebra
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): Q'apel Medical Inc.; 4245 technology drive; fremont CA 94538
• Manufacturer (Section G): Q'apel Medical Inc.; 4245 technology drive; fremont CA 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont, CA 94538
• MDR Report Key: 50187258
• Report Number: 3015614-2026-00028
• Device Sequence Number: 10141917
• Product Code: DQY
• UDI-Device Identifier: 00857545008400
• UDI-Public: 00857545008400
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K240746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG 02845-02
• Device Catalogue Number: AC6074-105
• Device Lot Number: FG260401B-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/08/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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
• Patient Sex: Unknown