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

Catalog Number 221-15-1000U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 04/16/2020

Event Type  Injury  

Event Description

During a procedure, a teleport microcatheter was used to cross a highly calcified, stenotic lesion in the anterior tibial artery where there was mild tortuosity.The lesion was difficult to cross, however, the microcatheter crossed successfully with multiple rotations.When the microcatheter was removed, the microcatheter was unwinding.The microcatheter did not fracture, and no fragments were left in the patient.No patient complications were reported, and the patient was stable following the procedure.The microcatheter will be returning.Patient co-morbidities include rc6.

• Brand Name: TELEPORT MICROCATHER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD.; 1 jinkui road; futian free trade zone; shenzhen, shenzhen 51803 8, C; CH 518038, CH
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1 jinkui road; futian free trade zone; shenzhen, shenzhen 51803 8, C; CH 518038, CH
• Manufacturer Contact: samantha chan ; 1 jinkui road; futian free trade zone; shenzhen, shenzhen 51803-8, C ; CH 518038, CH
• MDR Report Key: 10023080
• MDR Text Key: 189853468
• Report Number: 3003775186-2020-01638
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 221-15-1000U
• Device Lot Number: 4304741911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2020
• 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): Other