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	07/08/2023
Type of Reportable Event	Malfunction
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 fg220811j-03 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 07/08/2023.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) (cmo) and (b)(6) dated 10/31/2023, 3 cases from the same hospital and attending physician were reported to q'apel quality.Case 2 preliminary information was communicated to q'apel quality on 10/31/2023.Unclear, at the time of the complaint open date, if the patient required medical intervention."dissection after using walrus".M2 closure on the right.When the walrus advances to the entrance of the pelvic bone, asystole, after withdrawal spontaneous rhythm again, but persistent atrial fibrillation.Especially small dissection in the proximal cervical aci without hemodynamic relevance.(b)(4) will report findings for case 2 as documented in emails and physician's reporting notes.

• Brand Name: WALRUS 087 BALLOON GUIDE CATHETER
• Common Device Name: CATHETER INTRODUCER,
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont CA 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: 19226670
• Report Number: 3015614180-2024-00004
• Device Sequence Number: 5919377
• 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: 09/19/2025
• Device Model Number: 087 BALLOON GUIDE CATHETER
• Device Catalogue Number: BG8087-095
• 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: 10/26/2023
• Initial Report FDA Received Date: 05/01/2024
• 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: Other
• Patient Sex: Unknown