MAUDE Adverse Event Report: ORBUSHNEICH MEDICAL CO., LTD. TELEPORT MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	220-13-1000U
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A heavily calcified proximal and mid left anterior descending artery (lad) were the target treatment area.A 7f guide catheter and non-csi or abbott guide wire were advanced, then several trek balloons were advanced and inflated to pre dilate the vessel.Shockwave and intravascular ultrasound (ivus) were then attempted to be advanced but were unsuccessful due to the heavy calcification of the vessel.The teleport microcatheter was advanced, and a wire exchanged was performed for the viperwire advance guide wire.The teleport was removed and as the diamondback 360 coronary orbital atherectomy device (oad) was being prepared to be advanced onto the viperwire, the fluoroscope was checked, and a dark spot was observed on the viperwire.The teleport was checked, and it was discovered the radiopaque tip had fractured and was in vivo.A non-csi or abbott guide wire and a trapper balloon were advanced to attempt to secure the teleport tip but was unsuccessful.It was then observed, when the viperwire was moved the teleport tip moved with the viperwire.The teleport tip was stuck onto the viperwire and the two were removed together through the guide catheter.No component was left in the patient.A non-csi or abbott microcatheter was advanced over the non-csi or abbott guide wire and a wire exchanged was performed for the viperwire.The diamondback 360 coronary orbital atherectomy device (oad) was then advanced onto the viperwire and spun for four successful treatments.The patient was stable and did not experience impact from the reported issue.
Additional Manufacturer Narrative
Abbott was the distributor/importer for this device, the investigation and reporting of this event will be performed by the manufacturer.Csi id: (b)(4).

• Brand Name: TELEPORT MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ORBUSHNEICH MEDICAL CO., LTD.; no. 1 jinkui road; futian free trade zone; shenzhen 51803 8; CH 518038
• MDR Report Key: 18949006
• Report Number: 3004742232-2024-00120
• Device Sequence Number: 7906278
• Product Code: DQY
• UDI-Device Identifier: 06934955943058
• UDI-Public: (01)06934955943058(11)220509(17)240509(10)4301772205
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2024
• Report Date (Section F): 03/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Model Number: 220-13-1000U
• Device Catalogue Number: 7-10061-01
• Device Lot Number: 4301772205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2024
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/24/2024