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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: unable to determine root cause.The information provided to q'apel does not state that a product malfunction occurred.An adverse event appears to have occurred but there is not enough information available to classify the device problem.Fg 00100-02, lot fg220817j-02 was not returned to q'apel.
Event or Problem Description
Retroactive reporting to the fda of an incident that occured in the eu market (germany) on 06/25/2023.Q'apel medical became aware of the incident on 10-26-2023.Q'apel medical filed an mir report on 11/10/2023.Reason for complaint: dissection after using walrus.In an email from (b)(6) dated 10/31/2023, 3 cases from the same hospital and attending physician were reported to q'apel quality.(b)(6) will report findings for case 3 as documented in emails and physician's reporting notes."dissection after using walrus" thrombectomy of m2 segment type of injury and location: dissection in 2 parts of ica ( petrous and cavernous).M2 closure on the right.Placement in the cavernous segment.After thrombectomy kl.Dissection under the entrance to the rock bone and in the horizontal section of the pars petrosa.After 1 d closure of the aci: 2 dissections, one at the entrance to the pelvic leg, a second cavernous where the balloon was inflated.Recanalization with 2 stents.

• Brand Name: WALRUS 087 BALLOON GUIDE CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont 94538
• Manufacturer (Section G): Q'APEL MEDICAL INC.; 46708 lakeview blvd.; fremont 94538
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont 94538
• MDR Report Key: 19226933
• Report Number: 3015614180-2024-00005
• Device Sequence Number: 20313321
• Product Code: DQY
• UDI-Device Identifier: 00857545008028
• UDI-Public: 00857545008028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2025
• Device Model Number: 087 BALLOON GUIDE CATHETER
• Device Catalogue Number: BG8087-095
• Device Lot Number: FG220817J-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown