WALRUS 087 BALLOON GUIDE CATHETER

Additional Manufacturer Narrative

CONCLUSION: UNABLE TO DETERMINE ROOT CAUSE. THE INFORMATION PROVIDED TO Q'APEL DOES NOT STATE THAT A PRODUCT MALFUNCTION OCCURRED. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE DEVICE PROBLEM. FG 00100-02, LOT FG220817J-02 WAS NOT RETURNED TO Q'APEL.

Description of Event or Problem

RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE EU MARKET (GERMANY) ON 06/25/2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON 10-26-2023. Q'APEL MEDICAL FILED AN MIR REPORT ON 11/10/2023. REASON FOR COMPLAINT: DISSECTION AFTER USING WALRUS. IN AN EMAIL FROM (B)(6) DATED 10/31/2023, 3 CASES FROM THE SAME HOSPITAL AND ATTENDING PHYSICIAN WERE REPORTED TO Q'APEL QUALITY. (B)(6) WILL REPORT FINDINGS FOR CASE 3 AS DOCUMENTED IN EMAILS AND PHYSICIAN'S REPORTING NOTES. "DISSECTION AFTER USING WALRUS" THROMBECTOMY OF M2 SEGMENT TYPE OF INJURY AND LOCATION: DISSECTION IN 2 PARTS OF ICA ( PETROUS AND CAVERNOUS). M2 CLOSURE ON THE RIGHT. PLACEMENT IN THE CAVERNOUS SEGMENT. AFTER THROMBECTOMY KL. DISSECTION UNDER THE ENTRANCE TO THE ROCK BONE AND IN THE HORIZONTAL SECTION OF THE PARS PETROSA. AFTER 1 D CLOSURE OF THE ACI: 2 DISSECTIONS, ONE AT THE ENTRANCE TO THE PELVIC LEG, A SECOND CAVERNOUS WHERE THE BALLOON WAS INFLATED. RECANALIZATION WITH 2 STENTS.