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

Catalog Number	220-13-1000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The teleport microcatheter was placed over an externalized r350 wire and married up to the 150cm corsair pro catheter which was in the retrograde position in the lad septals and circumflex cto.The teleport and corsair catheters became locked together and were unable to be pulled apart.The hub of the corsair was cut and an attempt was made to remove the devices via antegrade access.When the physician pulled on the teleport, the catheter would not withdraw until the use of excessive force.All devices were removed from the patient, the vessel was re-wired and the procedure was completed with no patient complications.Exposed wire was noted on the teleport after removal.All devices were removed and no device remained in the patient.Return of the device is anticipated.

• Brand Name: TELEPORT MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• MDR Report Key: 8446666
• Report Number: 3014148220-2019-00001
• Device Sequence Number: 428997
• Product Code: DQY
• UDI-Device Identifier: 06934955943058
• UDI-Public: 06934955943058
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2020
• Device Catalogue Number: 220-13-1000
• Device Lot Number: 4307261811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/12/2019
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2019
• 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