inforMED
InjuryDQY

WALRUS 087 BALLOON GUIDE CATHETER

Received Oct 4, 2024

Report 3015614180-2024-00022 · MDR key 20374377

Device

Generic name

Catheter Introducer,, Product Code: Dqy

Catalog 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

45 YR · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

ICA DISSECTION (PETROUS SEGMENT); DISTAL EMBOLI IN SAME TERRITORY 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. ADDITIONAL INFORMATION ABOUT THE PATIENT: (B)(6), AGE OF PATIENT - 45, GENDER - MALE, 1ST RUN - 8:01, LOCATION OF CLOT - DISTAL M1 (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.

Additional Manufacturer Narrative

ICA DISSECTION (PETROUS SEGMENT); DISTAL EMBOLI IN SAME TERRITORY 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.