MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. JADE PTA; BALLOON DILATATION CATHETER

Catalog Number L540-15040

Device Problems Inflation Problem (1310); Difficult to Advance (2920)

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Perforation (2001); Stenosis (2263)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

Although there was a reportable patient injury,there was no obvious device malfunction in this stenosed, calcified and tortuous lesion and no clear indication that the device [prolapse] resulted in the vessel perforation.No remedial action is being performed by orbusneich in response to this event at this time.

Event Description

A ultraverse 2.0 was attempted to be inflated but could not cross.Then a ultraverse 1.25 could not cross either.The device crossed with difficulty and was inflated at 18 atm for 20 seconds.A ultraverse 2.0 was additionally inflated at 14 atm for 150 seconds with no vessel perforation.Then ata ostial and mid site was additionally treated after crossed by gladius.The device crossed the ata ostial with difficulty and the parent plus 3 fr 58 cm was managed to be advanced to bk3 bifurcation and inflated at 12 atm for 60 seconds.Subsequently the ata mid side could not be crossed so the parent plus 3 fr 58 cm was delivered to around the ata ostial and the device was advanced with difficulty and inflated at 12 atm for 60 seconds.Just after that it was found the device got looped at around the bk bifurcation and removed outside the body.At the same time the patient's blood pressure decreased and the patient expressed severe pain so angiography was performed and at pop-bk (3-bifurcation) vessel perforation was confirmed.A sterling 4.0/40 mm was inflated at 12 atm for 1,140 seconds to stop bleeding but could not so the patient transferred to the surgery division to perform angiorrhaphy.No cine was provided.The physician's comment: when the ata mid side was treated the parent plus 3 fr 58 cm was pushed back to around pop when the jade was strongly pushed, which might have made the jade got looped.Pop-bk, 100 % stenosed, heavily calcified, slightly tortured, elective pta, ipsilateral approach; the device was not returned for investigation; the lesion was crossed using a parent plus 3 fr 58 cm, teleport and gladius.

• Brand Name: JADE PTA
• Type of Device: BALLOON DILATATION CATHETER
• 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: 8805827
• MDR Text Key: 151570163
• Report Number: 3003775186-2019-00012
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K173894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/07/2020
• Device Catalogue Number: L540-15040
• Device Lot Number: 4014251808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2019
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• 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
• Treatment: DESCR GUIDE WIRE
• Patient Outcome(s): Life Threatening