MAUDE Adverse Event Report: QAPEL MEDICAL INC 087 BALLOON GUIDE CATHETER; CATHETER INTRODUCER

Model Number 087 BALLOON GUIDE CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Type  Injury  

Event Description

The manufacturer became aware of the event on 2/2/2021 following a retrospective chart review research study.Dissection occurred during the procedure after successful thrombectomy.It was noted after the 087 balloon guide catheter was withdrawn into the common carotid artery, cervical projection demonstrated a dissection of the cervical segment of the internal carotid artery where the balloon guide catheter had been inflated.The physician commented that the balloon ws overinflated and may have caused the dissection.The dissection was treated with balloon angioplasty and stenting.Patient had a hemorrhagic conversion with worsening clinical status and required hemicraniectomy and evd placement.

• Brand Name: 087 BALLOON GUIDE CATHETER
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): QAPEL MEDICAL INC; 46708 lakeview blvd; fremont CA 94538
• Manufacturer (Section G): QAPEL MEDICAL INC; 46708 lakeview blvd; fremont CA 94538
• Manufacturer Contact: scott hosaka ; 46708 lakeview blvd; fremont, CA 94538 ; 6504501155
• MDR Report Key: 11402017
• MDR Text Key: 234412100
• Report Number: 3015614180-2021-00044
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 087 BALLOON GUIDE CATHETER
• Device Catalogue Number: BG 8087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR