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

Model Number	087 BALLOON GUIDE CATHETER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Retroactive reporting to the fda of an incident that occured in the uk market on 4/20/2023.Q'apel medical became aware of the incident on 4/20/2023.Q'apel medical filed an initial mir report on 4/26/23.Q'apel medical filed a final mir report on 5/24/23.Conclusion: the device did not malfunction.The operator confirmed he over-inflated according to the vessel size and did not follow recommendations or the manufacturer's instructions.Walrus used was the 90cm version bg8087-090 lot no.Fg220811j-03.Physician name: dr (b)(6).Hospital name: (b)(6) hospital.75 yo male with a right m1 occlusion suffering an acute ischemic stroke.Patient was treated under general anesthesia.Other devices utilized in the procedure were a sofia plus aspiration catheter, phennom 21 micro catheter and a solitaire stent.Retriever the walrus bgc was placed in the distal cervical segment of the r ica physician initially inflated the walrus with approx 0.3cc's of contrast/saline mix.They felt that the balloon was not stable so continued to inflate with maximum recommended volume of 0.6cc's.Physician completed one pass with the solitaire stent retriever and the sofia plus aspiration catheter.Once that maneuver was performed, they performed a contrast run to assess tici score, and immediately observed the ica dissection in the location where the balloon inflation.Physician removed the walrus bgc and replaced it with a neuron max catheter.He performed a 2nd pass with the solitaire and sofia plus.And achieved tici 3 physician then proceeded to stent the ica with a 7 x 40mm carotid stent patient had no clinical sequelae, and is doing well.".
Additional Manufacturer Narrative
Lbs 01151, rev.B (087 balloon guide catheter ifu, medenvoy ous) was reviewed revision at the time of release).The ifu provides the following warnings: do not exceed the maximum recommended balloon inflation volume.Excess inflation volume may rupture the balloon.Additionally, the ifu contains a balloon inflation table detailing the balloon volume and balloon diameter.User error: the device did not malfunction.The operator confirmed he over-inflated according to the vessel size.

• Brand Name: WALRUS 087 BALLOON GUIDE CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology; fremont 94538
• Manufacturer (Section G): Q'APEL MEDICAL INC.; 46708 lakeview blvd.; fremont 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont, CA 94538
• MDR Report Key: 18871670
• Report Number: 3015614180-2024-00002
• Device Sequence Number: 18112697
• Product Code: DQY
• UDI-Device Identifier: 00857545008011
• UDI-Public: 00857545008011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192525
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/25/2025
• Device Model Number: 087 BALLOON GUIDE CATHETER
• Device Catalogue Number: BG8087-090
• Device Lot Number: FG220811J-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male