ZEBRA

Description of Event or Problem

ON JANUARY 13, 2026, Q'APEL MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE REPORT WAS SUBMITTED IN NOVEMBER 2025 REGARDING A NEUROLOGICAL PROCEDURE REPORTEDLY PERFORMED IN (B)(6) 2025 AT BUTTERWORTH HOSPITAL (GRAND RAPIDS, MI). THE MEDWATCH NARRATIVE STATED: "A VASCULAR CATHETER WAS THREADED THROUGH AN AORTIC STENT, AND THE CATHETER TIP WAS SHEARED OFF AND RETAINED WITHIN STENT AFTER TREATMENT." Q'APEL MEDICAL INITIATED FOLLOW-UP EFFORTS UPON RECEIPT OF THE MEDWATCH REPORT. MULTIPLE GOOD-FAITH ATTEMPTS WERE MADE TO CONTACT THE REPORT AUTHOR TO OBTAIN ADDITIONAL CLINICAL DETAILS, INCLUDING CONFIRMATION OF THE REPORTED EVENT, PATIENT OUTCOME, DEVICE IDENTIFICATION (PRODUCT NAME, LOT NUMBER), AND AVAILABILITY OF THE DEVICE FOR RETURN EVALUATION. AS OF FEBRUARY 10, 2026, Q'APEL MEDICAL HAS NOT RECEIVED A RESPONSE TO THESE FOLLOW-UP REQUESTS. THE DEVICE REFERENCED IN THE MEDWATCH REPORT WAS NOT RETURNED TO Q'APEL MEDICAL. THEREFORE, NO PHYSICAL DEVICE EVALUATION, DIMENSIONAL INSPECTION, OR FAILURE ANALYSIS COULD BE PERFORMED. DUE TO LIMITED INFORMATION PROVIDED IN THE MEDWATCH REPORT AND THE LACK OF RESPONSE TO FOLLOW-UP ATTEMPTS, Q'APEL MEDICAL WAS UNABLE TO CONFIRM: THE SPECIFIC Q'APEL PRODUCT INVOLVED (IF ANY), THE LOT NUMBER, PROCEDURAL DETAILS, PATIENT OUTCOME, WHETHER RETRIEVAL INTERVENTION WAS REQUIRED, OR THE EXACT FAILURE MODE. THE COMPLAINT INVESTIGATION WAS LIMITED TO REVIEW OF THE MEDWATCH NARRATIVE PROVIDED BY FDA.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT AN ADMINISTRATIVE OMISSION IN THE INITIAL REPORT. THE RELATED MEDICAL DEVICE REPORT NUMBER (B)(4) ASSOCIATED WITH THE SAME EVENT WAS NOT INCLUDED IN BLOCK H10 (RELATED REPORT NUMBER) OF THE ORIGINAL SUBMISSION. THE RELATED REPORT NUMBER HAS NOW BEEN ADDED. NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS CHANGED.

Description of Event or Problem

ON JANUARY 13, 2026, Q'APEL MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE REPORT WAS SUBMITTED IN NOVEMBER 2025 REGARDING A NEUROLOGICAL PROCEDURE REPORTEDLY PERFORMED IN (B)(6) 2025 AT (B)(6). THE MEDWATCH NARRATIVE STATED: "A VASCULAR CATHETER WAS THREADED THROUGH AN AORTIC STENT, AND THE CATHETER TIP WAS SHEARED OFF AND RETAINED WITHIN STENT AFTER TREATMENT." Q'APEL MEDICAL INITIATED FOLLOW-UP EFFORTS UPON RECEIPT OF THE MEDWATCH REPORT. MULTIPLE GOOD-FAITH ATTEMPTS WERE MADE TO CONTACT THE REPORT AUTHOR TO OBTAIN ADDITIONAL CLINICAL DETAILS, INCLUDING CONFIRMATION OF THE REPORTED EVENT, PATIENT OUTCOME, DEVICE IDENTIFICATION (PRODUCT NAME, LOT NUMBER), AND AVAILABILITY OF THE DEVICE FOR RETURN EVALUATION. AS OF FEBRUARY 10, 2026, Q'APEL MEDICAL HAS NOT RECEIVED A RESPONSE TO THESE FOLLOW-UP REQUESTS. THE DEVICE REFERENCED IN THE MEDWATCH REPORT WAS NOT RETURNED TO Q'APEL MEDICAL. THEREFORE, NO PHYSICAL DEVICE EVALUATION, DIMENSIONAL INSPECTION, OR FAILURE ANALYSIS COULD BE PERFORMED. DUE TO LIMITED INFORMATION PROVIDED IN THE MEDWATCH REPORT AND THE LACK OF RESPONSE TO FOLLOW-UP ATTEMPTS, Q'APEL MEDICAL WAS UNABLE TO CONFIRM: THE SPECIFIC Q'APEL PRODUCT INVOLVED (IF ANY), THE LOT NUMBER, PROCEDURAL DETAILS, PATIENT OUTCOME, WHETHER RETRIEVAL INTERVENTION WAS REQUIRED, OR THE EXACT FAILURE MODE. THE COMPLAINT INVESTIGATION WAS LIMITED TO REVIEW OF THE MEDWATCH NARRATIVE PROVIDED BY FDA.