WALRUS 087 BALLOON GUIDE CATHETER

Description of Event or Problem

RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE UK MARKET ON 4/20/2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON 4/20/2023. Q'APEL MEDICAL FILED AN INITIAL MIR REPORT ON 4/26/23. Q'APEL MEDICAL FILED A FINAL MIR REPORT ON 5/24/23. CONCLUSION: THE DEVICE DID NOT MALFUNCTION. THE OPERATOR CONFIRMED HE OVER-INFLATED ACCORDING TO THE VESSEL SIZE AND DID NOT FOLLOW RECOMMENDATIONS OR THE MANUFACTURER'S INSTRUCTIONS. WALRUS USED WAS THE 90CM VERSION BG8087-090 LOT NO. FG220811J-03. PHYSICIAN NAME: DR (B)(6). HOSPITAL NAME: (B)(6) HOSPITAL. 75 YO MALE WITH A RIGHT M1 OCCLUSION SUFFERING AN ACUTE ISCHEMIC STROKE. PATIENT WAS TREATED UNDER GENERAL ANESTHESIA. OTHER DEVICES UTILIZED IN THE PROCEDURE WERE A SOFIA PLUS ASPIRATION CATHETER, PHENNOM 21 MICRO CATHETER AND A SOLITAIRE STENT. RETRIEVER THE WALRUS BGC WAS PLACED IN THE DISTAL CERVICAL SEGMENT OF THE R ICA PHYSICIAN INITIALLY INFLATED THE WALRUS WITH APPROX 0.3CC'S OF CONTRAST/SALINE MIX. THEY FELT THAT THE BALLOON WAS NOT STABLE SO CONTINUED TO INFLATE WITH MAXIMUM RECOMMENDED VOLUME OF 0.6CC'S. PHYSICIAN COMPLETED ONE PASS WITH THE SOLITAIRE STENT RETRIEVER AND THE SOFIA PLUS ASPIRATION CATHETER. ONCE THAT MANEUVER WAS PERFORMED, THEY PERFORMED A CONTRAST RUN TO ASSESS TICI SCORE, AND IMMEDIATELY OBSERVED THE ICA DISSECTION IN THE LOCATION WHERE THE BALLOON INFLATION. PHYSICIAN REMOVED THE WALRUS BGC AND REPLACED IT WITH A NEURON MAX CATHETER. HE PERFORMED A 2ND PASS WITH THE SOLITAIRE AND SOFIA PLUS. AND ACHIEVED TICI 3 PHYSICIAN THEN PROCEEDED TO STENT THE ICA WITH A 7 X 40MM CAROTID STENT PATIENT HAD NO CLINICAL SEQUELAE, AND IS DOING WELL."

Additional Manufacturer Narrative

LBS 01151, REV. B (087 BALLOON GUIDE CATHETER IFU, MEDENVOY OUS) WAS REVIEWED REVISION AT THE TIME OF RELEASE). THE IFU PROVIDES THE FOLLOWING WARNINGS: DO NOT EXCEED THE MAXIMUM RECOMMENDED BALLOON INFLATION VOLUME. EXCESS INFLATION VOLUME MAY RUPTURE THE BALLOON. ADDITIONALLY, THE IFU CONTAINS A BALLOON INFLATION TABLE DETAILING THE BALLOON VOLUME AND BALLOON DIAMETER. USER ERROR: THE DEVICE DID NOT MALFUNCTION. THE OPERATOR CONFIRMED HE OVER-INFLATED ACCORDING TO THE VESSEL SIZE.