WALRUS 087 BALLOON GUIDE CATHETER
Received Jun 24, 2024 · Event occurred Apr 25, 2024
Report 3015614180-2024-00008 · MDR key 19602376
Device
Generic name
Catheter Introducer
Manufacturer
Q'apel Medical Inc.Model number
087 BALLOON GUIDE CATHETERCatalog number
BG8087--95
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
66 YR · Male
- Vascular Dissection
- Vascular Dissection
Narrative
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION, Q'APEL MEDICAL IS UNABLE TO CONFIRM THE REPORTED EVENT AND DETERMINE IF A PRODUCT MALFUNCTION OCCURRED.
Description of Event or Problem
ON 5/28/2024, Q'APEL MEDICAL RECEIVED AN EMAIL FROM THE FDA NOTIFYING THE COMPANY OF A VOLUNTARY MDR THAT WAS SUBMITTED ON 5/5/2024. PER THE REPORTED PROBLEM STATEMENT: "CERVICAL LEFT INTERNAL CAROTID ARTERY DISSECTION AT SITE OF WALRUS BALLOON GUIDE CATHETER INFLATION WITH CONTRAST POOLING IN FALSE LUMEN, CREATING FUSIFORM DILATION AND REQUIRING ANTIPLATELET USE (ASPIRIN) TO PREVENT THROMBOEMBOLISM. THIS OCCURRED AFTER MECHANICAL THROMBECTOMY FOR INTRACRANIAL LARGE-VESSEL OCCLUSION (LEFT MIDDLE CEREBRAL ARTERY OCCLUSION). 95-CM 8F WALRUS BGC." THE LOCATION PROVIDED WAS THE USA. NO OTHER INFORMATION WAS PROVIDED IN THE REPORT.