MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SAPPHIRE II PRO SZ PTCA BALLOON

Catalog Number 215-153-5UU

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problems Calcium Deposits/Calcification (1758); Vascular Dissection (3160)

Event Date 06/06/2022

Event Type  Injury  

Event Description

Atherectomy was performed in the left anterior descending (lad) artery, followed by balloon angioplasty.The vessel was heavily calcified throughout.The sapphire balloon was inflated in the proximal to mid lad, distal to the heavily calcified atherectomy treated segment.A dissection was noticed, and flow was diminished.A balloon was advanced, followed by stent placement in the distal end of the lad and covered the distal edge of the dissection area.Multiple attempts were made to advance additional balloons and stents to cover the area between the distal and proximal stents.Following stent deployment, wire access was lost, and the vessel was rewired.Neither non-csi balloons, nor stents were able to advance through the lesion.A sapphire balloon was then advanced through the lesion, the balloon appeared to be within the stent and vessel lumen with no areas of waist observed during the inflation.The balloon burst while being inflated within the distal segment of the lad artery beyond a large diagonal branch, proximal to a newly placed stent.The sapphire balloon was then removed, and other balloons were advanced through the lesion.No stent was able to be advanced through the lesion.The dissection proximal to the most distal stent remained after multiple attempts.Angiography revealed the flow to the lad and diagonal branch to be brisk.The procedure was then completed and the patient was hemodynamically stable.The balloon will be returned.

• Brand Name: SAPPHIRE II PRO SZ PTCA BALLOON
• Type of Device: SAPPHIRE II PRO SZ PTCA BALLOON
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; cn 518038, cn 518038 ; CH
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen guangdong,, shenzhen guangdong, 51803 8; CH 518038
• Manufacturer Contact: samantha chan ; no.1st jinkui road; futian free trade zone; shenzhen guangdong,, shenzhen guangdong 51803-8 ; CH 518038
• MDR Report Key: 14849187
• MDR Text Key: 294904829
• Report Number: 3003775186-2022-01854
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163114
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 215-153-5UU
• Device Lot Number: 425731208
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• 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