MAUDE Adverse Event Report: Q'APEL MEDICAL 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	09/22/2023
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 00100-01, 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 (b)(6) 2023.Q'apel medical became aware of the incident on (b)(6) 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: "dissection after using walrus" "m2 closure on the left.S-shaped elongation of proximal aci, insurmountable with walrus, after extraction v.A.Dissection (not hemodyn.Effective).Information was communicated to q'apel quality on 10/31/2023.Unclear, at the time of complaint open date, if the patient required medical intervention.Q'apel personnel have made three attempts to request for detailed information regarding the incident.Data regarding the incident will not be collected by the doctor according to the email from the q'apel sales representative dated on 11/02/2023.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 00100-01, lot fg220817j-02 was not returned to q'apel.

• Brand Name: WALRUS 087 BALLOON GUIDE CATHETER
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): Q'APEL MEDICAL; 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: 19224693
• Report Number: 3015614180-2024-00003
• Device Sequence Number: 8241680
• 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): 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
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• 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