inforMED
InjuryDQY

WALRUS 087 BALLOON GUIDE CATHETER

Received Feb 27, 2025 · Event occurred Jan 24, 2025

Report 3015614180-2025-00003 · MDR key 21483290

Device

Generic name

Catheter Introducer

Catalog number

BG8087--95

Lot number

FG240820M-04

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

72 YR · Male

  • Aortic dissection
  • Aortic dissection

Narrative

Description of Event or Problem

Q'APEL MEDICAL MADE MULTIPLE GOOD-FAITH EFFORTS TO COMMUNICATE WITH THE PHYSICIAN TO GATHER MORE INFORMATION REGARDING THE EVENT. DATE OF EVENT: 1/24/2025. PRODUCT WALRUS 95CM LOT# FG240820M-04. THE PHYSICAN'S NARATIVE THE DEVICE WAS PREPARED PER THE IFU AND THE Q'APEL SUPPLIED INTRODUCER SHEATH WAS USED. ISSUE: DIFFICULTY ADVANCING WALRUS THROUGH THE TERUMO 8F PINNACLE SHEATH. "I ENDED UP DISSECTING THE AORTA BECAUSE I WAS PUSHING TOO HARD, AND I GUESS IT SCRAPPED OFF THE INTIMA OF AORTA. " PROCEDURE AND PATIENT OUTCOME: THROMBECTOMY, MALE, 72YO. MEDICAL INTERVENTION REQUIRED? IF SO, WHAT: "NO INTERVENTION WAS DONE FOR THIS".

Additional Manufacturer Narrative

THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY THE FDA, Q'APEL MEDICAL, OR ITS EMPLOYEES THAT THE DEVICE, Q'APEL MEDICAL, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED. ANY REQUIRED FIELDS THAT REMAIN UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. Q'APEL MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. Q'APEL MEDICAL MADE MULTIPLE GOOD-FAITH EFFORTS TO COMMUNICATE WITH THE PHYSICIAN TO GATHER MORE INFORMATION REGARDING THE EVENT. ON (B)(6) 2025, THE PHYSICIAN STATED THAT THE DEVICE WAS PREPARED ACCORDING TO THE IFU AND THAT THE Q'APEL-SUPPLIED INTRODUCER SHEATH WAS USED. THE PHYSICIAN NOTED DIFFICULTY ADVANCING THE WALRUS CATHETER THROUGH THE TERUMO 8F PINNACLE SHEATH. ACCORDING TO THE PHYSICIAN'S STATEMENT: "I ENDED UP DISSECTING THE AORTA BECAUSE I WAS PUSHING TOO HARD, AND I GUESS IT SCRAPED OFF THE INTIMA OF THE AORTA. I WAS ABLE TO FIT THE WALRUS THROUGH THE SHEATH, BUT IT WAS TOO TIGHT." Q'APEL MEDICAL'S PUBLISHED MARKET DOCUMENT, MKT 01351 (REV. A) - WALRUS 8F SHEATH COMPATIBILITY, SPECIFIES THE EXPECTED COMPATIBILITY OF VARIOUS 8F SHEATHS. THE TERUMO PINNACLE 8F SHEATH IS LISTED AS A "TIGHT FIT". Q'APEL MEDICAL WAS UNABLE TO DETERMINE THE ROOT CAUSE AND THE DEVICE WAS NOT RETURNED. THE REPORTED EVENT OF A TIGHT FIT IS A PUBLISHED POTENTIAL FAILURE PER MKT 01351.