MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE II PRO CORONARY DILATATION CATHETER

Catalog Number 220-153-5UJ

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Microscope examination of the balloon revealed that there was a slit with a length of approximately 9mm on the proximal of the balloon.Apart from above observed damage, no other anomalies were found on the returned device.During the manufacturing processes each catheter is inflated to its rated burst pressure (14atm) to check for leaks prior to release.Each unit is packaged with a balloon sheath to protect it from any external damage.The slit on the balloon was likely not present prior to being used as it would have been detected during the manufacturing leak test and rejected.A review of the manufacturing records for this lot did not reveal any non-conformities which could have contributed to the complaint.Based on the spc review, all burst values of sapphire ii pro 2.0mm balloon were over the lower control limit (lcl) and remaining stable, implying that the balloon forming process is in compliance with the product specification and under control.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.The root cause of this complaint could not be fully ascertained.Factors that could have contributed to this complaint may be related to the interaction between the balloon material and the calcified lesion, sharp object, interaction with other devices, patient anatomy, lesion calcification, or lesion tortuosity.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 balloon was burst below rbp.Inflation pressure is 12 atm.

• Brand Name: SAPPHIRE II PRO CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: li li ; 1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 8454638
• MDR Text Key: 140151779
• Report Number: 3003775186-2019-00005
• Device Sequence Number: 0
• Product Code: LOX
• Reporter Country Code: HK
• PMA/PMN Number: K163114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2020
• Device Catalogue Number: 220-153-5UJ
• Device Lot Number: 4283521811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2018
• 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