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

Catalog Number 210-153-5UU

Device Problems Failure to Advance (2524); No Flow (2991); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  Injury  

Event Description

A catheter was unable to pass through a pre-existing stent in the right coronary artery, which was jailing the patent ductent arteriosus (pda) ostium.A sapphire balloon was able to pass through and was inflated to expand the stent struts.During removal the balloon became stuck and could not be pulled back until an unusual amount of force was used to remove it.Upon removal, it was noted that the balloon catheter was torn open and missing the radiopaque marker.Nothing else was able to pass through the stent and the marker and portion the balloon material were left in vivo and as a result the pda did not have any flow.The patient was discharged in stable condition without any issues observed.Per the physician, the no flow event was due to being unable to obtain the balloon materials left in vivo.

• Brand Name: SAPPHIRE II PRO
• Type of Device: SAPPHIRE II PRO BALLOON DILATATION CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD.; 1 jinkui road; futian free trade zone; shenzhen 518038,, shenzhen 518038, 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; 1 jinkui road; futian free trade zone; shenzhen, shenzhen 51803 8; CH 518038
• Manufacturer Contact: samantha chan ; 1 jinkui road; futian free trade zone; shenzhen, shenzhen 51803-8 ; CH 518038
• MDR Report Key: 12637502
• MDR Text Key: 276584683
• Report Number: 3003775186-2021-03639
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180921
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 210-153-5UU
• Device Lot Number: 4253212009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention