MAUDE Adverse Event Report: Q'APEL MEDICAL INC. WAHOO; SELECTFLEX 072 NEUROVASCULAR ACCESS SYSTEM, 105CM

Model Number	FG 00074
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a retrospective legacy complaint file review for potential mdr reportable events, (b)(4) (event date-01/13/2021), was observed to have met the reportability criteria after the investigation of the returned product was completed ((b)(6) 2021).Note: on (b)(6) 2023, q'apel medical inc.Decided to cease the production of wahoo selectflex 072 neurovascular access system.Timeline of events: -(b)(4) initial mdr evaluation: at the time of the complaint, q'apel medical determined the event was not reportable under 21 cfr 803.50 based on available information.Specifically, the evaluation concluded the device did not: 1.Cause or contribute to a death or serious injury; or 2.Malfunction in a way that, if it were to recur, would likely result in a death or serious injury.-case overview (provided by sales representative): 1.Wahoo catheter was tracked to the target anatomy and used to deploy a surpass flow diverter.2.Upon attempt to pass a wire post-deployment, resistance was noted.3.Resistance during withdrawal prompted simultaneous removal of the wahoo and 8f sheath.4.Initial inspection suggested the catheter was intact.5.The patient had highly tortuous vasculature.No harm was reported during or after the procedure.-returned product analysis performed on (b)(6) 2021: returned items included the wahoo catheter and inflation syringe.Key findings included: 1.One kink observed 120 mm from the distal tip upon manipulation.2.Vacuum leak test revealed leakage; fluid was seen exiting at 114 mm from the tip.Endoscopic inspection revealed: 1.Kinks at 120 mm and 80 mm.2.Liner delamination from 55-67 mm, with red discoloration and axial stretch marks.3.No material missing, but impingement into the lumen was noted.-returned product analysis root cause: the probable root cause of the malfunction was identified as design-related stress failure of the liner material under tortuous anatomical conditions, potentially due to improper material selection or bonding.-capa-0011 was initiated to investigate the failure and identify design improvements.The investigation found that two conditions are necessary for delamination: 1.Excessive bending that weakens the bond between the liner and jacket material; and 2.An inflation fluid pathway that allows pressurized fluid to access the weakened interface.The design was deemed inadequate as it allowed fluid communication between the inflation lumen and the top of the coil in a segment of the catheter subject to high deformation.The coil surface did not form a fluid-tight bond to the jacket, allowing transmission of pressurized fluid to the compromised liner.A design modification to increase jacket coverage over the coil confirmed the root cause, as the updated configuration significantly reduced or eliminated delamination.All corrective actions met effectiveness verification criteria, and the capa was closed on 08/31/2021.-mdr reassessment ((b)(6) 2024): based on the additional information obtained during the returned product analysis, the device was confirmed to have malfunctioned in a manner that could lead to serious injury if the failure mode were to recur.Specifically, the liner delamination and catheter wall permeability represent failures that could compromise catheter performance and pose clinical risks during similar use conditions.The complaint meets mdr reporting criteria under 21 cfr 803.50(b)(2).

• Brand Name: WAHOO
• Common Device Name: SELECTFLEX 072 NEUROVASCULAR ACCESS SYSTEM, 105CM
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont CA 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont
• MDR Report Key: 21952073
• Report Number: 3015614180-2025-00005
• Device Sequence Number: 12851706
• Product Code: DQY
• UDI-Device Identifier: 00857545008004
• UDI-Public: 00857545008004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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 Expiration Date: 10/16/2021
• Device Model Number: FG 00074
• Device Catalogue Number: SF7072-105
• Device Lot Number: FG200928-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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