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

Catalog Number 221-13-100U

Device Problems Entrapment of Device (1212); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint products, teleport microcatheter 2.1f x 135cm with associated wire were returned for evaluation.Per gross examination: dried blood could be found in the returned teleport.The wire was found to be stuck in the distal part of the teleport microcatheter and the distal part of the wire was missing.No information was provided for the missing distal part of the wire and it was not returned for analysis.There was severely stretched was found in the distal shaft (coil) of teleport microcatheter, and the failure mode / appearance is consistent with stretching due to external force applied to the microcatheter.The distal tip of the microcatheter was found to be slightly damaged with scrolled ends3.Measured the stretched catheter distal shaft (coil) revealed that it has been stretched approximately 10.0cm.The wire was removed from the teleport microcatheter and no abnormalities were found on the remained proximal part of the wire.Apart from above observed damages, no other anomalies were found on the returned devices.No case image cd was provided for analysis.A review of the clinical information for this complaint indicated that a guidewire (regalia 0.014 wire) became stuck in a teleport microcatheter (2.1f x 135cm) when an attempt was made to exchange the regalia wire for a viperwire and after the teleport was crossed the cto lesion along a regalia 0.014 wire and then removed the wire, injected contrast to confirm lumen, flushed the teleport, and then inserted the regalia wire back into the teleport to wire distally.The returned teleport microcatheter and the associated wire were examined in the failure analysis laboratory.The analysis results are: the damage on the microcatheter shaft was not due to a manufacturing assembling failure.The failure mode / appearance of the teleport microcatheter is consistent damage due to distal portion trapped by inner wire (such as the regalia 0.014 wire) and / or out harder lesions and further elongated by excessive pulling force.There are no signs of manufacturing defects on the returned product and / or the lot information from this product.Based on the above investigation, the possible root cause identified is operational context as device performance was limited due to anatomical procedure factors.This complaint has been shared with the manufacturing and engineering teams.We will keep the complaint on file for future statistical analysis and monitoring.No remedial action is being performed by orbusneich in response to this event at this time.

Event Description

The lesion was reported as a sfa lesion with moderately calcified and 99% stenosis.The physician crossed the cto lesion with a regalia 0.014 wire and 135cm teleport control.The physician then removed the wire, injected contrast to confirm lumen, flushed the teleport, and then inserted the regalia wire back into the teleport to wire distally.An attempt was then made to exchange the regalia wire for a viperwire, but the regalia would not come out of the teleport.Dr.Patel struggled to remove wire for brief moment before deciding to remove the whole system and start over.Tried removing regalia wire outside of the body at the table and was unsuccessful.

• Brand Name: TELEPORT MICROCATHETER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: li li ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 8507858
• MDR Text Key: 151939313
• Report Number: 3003775186-2019-00008
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 06934955943072
• UDI-Public: 06934955943072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2019

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
• Device Operator: No Information
• Device Expiration Date: 11/23/2020
• Device Catalogue Number: 221-13-100U
• Device Lot Number: 4307301811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/15/2019
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• 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
• Patient Outcome(s): Death; Life Threatening