• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Q'APEL MEDICAL WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

Q'APEL MEDICAL WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER Back to Search Results
Model Number 087 BALLOON GUIDE CATHETER
Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem Vascular Dissection (3160)
Event Date 06/17/2021
Event Type  Injury  
Event Description

During the procedure, the internal carotid artery was dissected at the location of the walrus balloon guide catheter balloon. The clinician noted that he likely over-inflated the balloon during the procedure. A therapeutic occlusion of the right carotid artery was performed to treat the dissection by deploying microvascular plugs above and below the transmural dissection. The patient was reported as doing well. During the procedure the walrus balloon guide catheter kinked. Upon removal a small piece of the aspiration catheter (react 71) was found in the central lumen of the walrus catheter. The kink in the walrus catheter and the damage to the aspiration catheter were not related to the patient injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWALRUS 087 BALLOON GUIDE CATHETER
Type of DeviceCATHETER INTRODUCER
Manufacturer (Section D)
Q'APEL MEDICAL
46708 lakeview blvd
fremont CA 94538
Manufacturer (Section G)
Q'APEL MEDICAL INC
46708 lakeview blvd
fremont CA 94538
Manufacturer Contact
scott hosaka
46708 lakeview blvd
fremont, CA 94538
6504501155
MDR Report Key12181493
MDR Text Key262164304
Report Number3015614180-2021-00064
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK192525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number087 BALLOON GUIDE CATHETER
Device Catalogue NumberBG 8087
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2021 Patient Sequence Number: 1
-
-