MAUDE Adverse Event Report: MEDTRONIC MEXICO CATHERA; CATHETER, NEURO-VASCULATURE, OCCLUDING BALLOON

Model Number	FG19120-1030-1S
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received from medwatch: mw5104101.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
2021-oct-04 mw5104101 (oth): medtronic received information that a phenom catheter tip had sheared off and a second marker tip was noticed on a qapel wahoo catheter.It was reported that suboptimal apposition of the stent at the distal end and introduced a transform 7x7mm balloon along with the traxcess microwire.During the introduction of the microcatheter, it was noticed there was a second radio-opaque marker at the tip of the wahoo just as the microwire was about to reach the end of the wahoo tip.However, by then, it was too late as the microwire gently touched the radio-opaque marker and it travelled distally into the left distal pca.It was at this time that the phenom plus catheter was checked and noted that the tip was sheared off.However, given the distal location of the current marker tip location, and it does not appear to be occlusive.Repeat angiogram did not show thrombosis.We felt that it would be safer to leave it as it is.

• Brand Name: CATHERA
• Common Device Name: CATHETER, NEURO-VASCULATURE, OCCLUDING BALLOON
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 12599164
• Report Number: 9612164-2021-03871
• Device Sequence Number: 11123576
• Product Code: PAV
• UDI-Device Identifier: 00763000399733
• UDI-Public: 00763000399733
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: FG19120-1030-1S
• Device Catalogue Number: FG19120-1030-1S
• Device Lot Number: 222009886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1