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

Model Number FG19120-1030-1S

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

Received from medwatch: mw5104101.If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: CATHETER, NEURO-VASCULATURE, OCCLUDING BALLOON
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12599164
• MDR Text Key: 276899002
• Report Number: 9612164-2021-03871
• Device Sequence Number: 1
• Product Code: PAV
• UDI-Device Identifier: 00763000399733
• UDI-Public: 00763000399733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/08/2021
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1