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

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263)

Event Date 07/19/2019

Event Type  Injury  

Event Description

A teleport microcatheter was used to obtain access distal to the anterior tibial artery (at) via antegrade/retrograde common femoral artery (cfa) to at approach.(the distal end of the guide wire exited the at access and remained ex vivo during the procedure.) the teleport was inserted through a 0.35 inch support catheter over the 0.14" guide wire.The teleport could not be advanced to the desired location due to a high level of stenosis and calcification.The teleport became stuck on the guide wire and could not be removed from the cfa access point.Since the physician preferred not to compromise wire access, the hub of the teleport was cut, and a balloon was used to push the teleport distal.A technician pulled the teleport through the at access point with gloved fingernails, and the teleport came apart and shredded as it was pulled from the access point.Once the teleport was removed, the guide wire was exchanged for a viper wire, and the physician was able to perform atherectomy on the lesion in the at.The case was completed with no injury to the patient.The target lesion was reported as a severe calcification.Patient status was reported as satisfactory.

• 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, 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: 9178267
• MDR Text Key: 162980161
• Report Number: 3003775186-2019-00479
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K182360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening