MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. TELEPORT MICROCATHETER

Catalog Number	221-15-1000U
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The teleport microcatheter was being used as a transfer catheter to exchange the workhorse wire for the csi viperwire via a radial approach.When an attempt was made to remove the teleport from the vessel, it appeared to seize up on the viperwire or be lodged against the distal aspect of the lesion in the rca.The teleport was unable to be torqued, advanced, or removed.The physician forcibly pulled all devices out of the rca and everything was removed.Additional femoral access was obtained and a fine cross catheter was used and would not cross the lesion.A second teleport microcatheter was inserted and successfully crossed the lesion.The viperwire was re-inserted and atherectomy treatment was performed at the distal lesion.Per the opinion of the physician, minimal improvement was obtained and due to the procedure approaching three hours in length, the decision was made to abort the procedure.The patient was in stable condition following the procedure and no complications were reported.An additional procedure at (b)(6) hospital is planned.The catheter will be returned for analysis.

• Brand Name: TELEPORT MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen, 51803 8; CH 518038
• MDR Report Key: 9178060
• Report Number: 3014148220-2019-00004
• Device Sequence Number: 18918677
• Product Code: DQY
• UDI-Device Identifier: 06934955943072
• UDI-Public: 06934955943072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 221-15-1000U
• Device Lot Number: 4307301811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• 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: Life Threatening