WALRUS 087 BALLOON GUIDE CATHETER
Received Aug 12, 2024
Report 3015614180-2024-00014 · MDR key 19969160
Device
Generic name
Catheter Introducer
Manufacturer
Q'apel Medical Inc.Model number
087 BALLOON GUIDE CATHETERCatalog number
BG8087--XX
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
58 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE EVENT WAS OBSERVED DURING A REVIEW OF CLINICAL DATA COLLECTED FOR POST-MARKET SURVEILLANCE OF WALRUS STROKE CASES IN THE UK. THE PROCEDURE DATE IS UNKNOWN. THE ATTENDING PHYSICIAN WAS ASKED FOR FOLLOW UP AND BASED ON HIS RECOLLECTION THE COMPLICATIONS WERE RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION RELATED TO THE CASE OR DEVICE WAS ABLE TO BE OBTAINED. Q'APEL MEDICAL HAS MADE GOOD FAITH EFFORTS BUT HAVE BEEN UNSUCCESSFUL (AT THE TIME OF SUBMISSION) IN OBTAINING ADDITIONAL INFORMATION RELATED TO THE CASE INCLUDING DATE OF PROCEDURE. 8 FR. SHORT SHEATH; SOFIA 6-FR ASPIRATION CATH; POWER SELECT + MICRO CATH; SYNCHRO SUPPORT MICRO WIRE; ET III 6.5MM X 45MM STENT; PATIENT AND PROCEDURE OUTCOME: THE PATIENT'S TICI SCORE IMPROVED FROM 0 TO 2B
Description of Event or Problem
DESCRIPTION OF COMPLAINT: DISTAL EMBOLI IN SAME TERRITORY (M4); ICA DISSECTION. THE EVENT WAS OBSERVED DURING A REVIEW OF CLINICAL DATA COLLECTED FOR POST-MARKET SURVEILLANCE OF WALRUS STROKE CASES IN THE UK. THE PROCEDURE DATE IS UNKNOWN. THE ATTENDING PHYSICIAN WAS ASKED FOR FOLLOW UP AND BASED ON HIS RECOLLECTION THE COMPLICATIONS WERE RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION RELATED TO THE CASE OR DEVICE WAS ABLE TO BE OBTAINED. Q'APEL MEDICAL HAS MADE GOOD FAITH EFFORTS BUT HAVE BEEN UNSUCCESSFUL (AT THE TIME OF SUBMISSION) IN OBTAINING ADDITIONAL INFORMATION RELATED TO THE CASE INCLUDING DATE OF PROCEDURE. (B)(6) AGE OF PATIENT - 58 GENDER - MALE 1ST RUN - 22:50 LOCATION OF CLOT - DISTAL M1 PLUS ICA (B)(6) TOTAL PASS-4 START TICI-0 FINAL TICI SCORE - 2B PATIENT AND PROCEDURE OUTCOME: THE PATIENT'S TICI SCORE IMPROVED FROM 0 TO 2B.