MAUDE Adverse Event Report: Q'APEL MEDICAL INC. ZEBRA; CATHETER, PERCUTANEOUS

Model Number	FG 01764-01
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated by engineering team personnel, and the reported event of device separation was confirmed.The evaluation determined that the failure was not related to a design, manufacturing, packaging, or labeling issue.Per the physician's account, no introducer sheath was used.However, the product instructions for use (ifu) direct the user to "place an appropriately sized introducer sheath into the primary access artery" when preparing the device for use.Failure to use an introducer sheath, as instructed in the ifu, may have increased the risk of device wall deformation (kinking) during navigation and manipulation.Additionally, the ifu warns that "unrestrained movement or torquing of the device against resistance may result in vessel or device damage." there were no retained fragments, no patient injury, and no additional medical intervention required for this event.A new zebra catheter from the same lot was used, this time with an introducer sheath.The procedure was successfully completed without further issues.
Event or Problem Description
Any required fields that remain unpopulated are blank because the information is currently unknown or unavailable.Q'apel medical will submit a supplemental report if additional relevant information becomes available.Q'apel medical made multiple good-faith efforts to communicate with the physician to gather more information regarding the event and the physician performing case confirmed the information stated below.Patient details-not provided, patient age: not provided, patient sex: not provided, medical considerations: scarred groin.Procedure details: no sheath was used initially a 6fr vascular dilator followed by a 7fr pre-dilator was used after needle puncture, micro puncture, and 0.035" wire insertion a q'apel dilator was used with a 7fr zebra catheter due to the absence of a sheath, the catheter was inserted manually, inch by inch some back pressure was noted during insertion a diagnostic catheter was inserted into the zebra after dilator removal over the wire.Issue encountered: under fluoroscopy, the diagnostic catheter did not move with the zebra as expected after approximately two minutes, active bleeding ("pinhole") from the side of the catheter was observed at the groin site.Upon attempting device removal, the zebra catheter separated, leaving a segment inside the patient.A 0.035" guidewire was used to successfully retrieve the remaining catheter segment no retained fragments, no patient injury, and no additional medical intervention was required.Resolution: a new zebra catheter (same lot) was used a sheath was inserted this time, and the procedure was successfully completed total procedure delay: 5 minutes.

• 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: 21515859
• Report Number: 3015614180-2025-00004
• Device Sequence Number: 20823794
• Product Code: DQY
• UDI-Device Identifier: 00857545008219
• UDI-Public: 00857545008219
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 07/06/2025
• Device Model Number: FG 01764-01
• Device Catalogue Number: AC7087-095-20-B
• Device Lot Number: FG250107C-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown