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

Catalog Number L540-15120

Device Problems Break (1069); Material Rupture (1546); Stretched (1601); Structural Problem (2506)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2021

Event Type  Injury  

Event Description

A jupiter was engaged and the device in question was delivered but could not cross the lesion so a tornus pv crossed the tightest site of the lesion.The device in question was delivered again to cross the lesion and inflated at 12 atm at the tightest site of the lesion with no problems.Then the device was delivered to distal and pulled back to proximal to inflate and the balloon ruptured at the tightest site of the lesion at the 5th inflation at 20 atm.The device was attempted to be pulled back but could not seemingly because got stuck at the lesion.Another gw of gladius and another jade 1.5/120 was used to dilate the proximal site of the lesion but the device still could not be pulled back.A distal puncture was performed and wire externalization was established to remove the device along with the gw and during removal the marker bands of the device and the radiopaque part of the gw dropped in the body, which indicated the device and gw broke off.The device was removed outside the body and some elongation was found at multiple sites with no balloon material but it was difficult to see from which part it was elongated or broke off because the gw got tangled in the device.The lesion was continuously dilated using bcs in larger size.An ivus was performed and the broken pieces were observed in the subbranch.Because good blood flow was fluoroscopically observed the physician decided to end the procedure with the broken pieces left in the body.Next day a surface echo was performed and it was confirmed the broken pieces were remained in pseudolumen and blood flow was excellent.The patient was released from the hospital in january 22nd and a follow-up date is set up to one month later.There are few kinks in the return device that occurred not during the procedure but during an attempt to pull away from the gw, which failed, after the procedure.The physician commented that the lesion was very tight and balloon rupture was within the assumption and the broken pieces were presumably not able to be surgically removed either.He thinks the whole balloon material is remained in the body but wants to know if there are any other pieces are also remained in the body other than the seemingly two marker bands and the partial gw fluoroscopically observed in the final angiogram by confirming if any marker bands are attached in the return device.He also wants to obtain an investigation result with many picture data in details that show which site of the device and how it broke off, etc. the physician and sr want to obtain the investigation result urgently as it is a case in which the procedure was ended with some broken pieces remained in the patient's body and the patient will continuously be monitored.Also at a pmda reportability point of view if an investigation result can be provided as soon as possible it will be helpful as it is a pmda reportable.Was the product used clinically?.

• Brand Name: JADE PTA
• Type of Device: JADE PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1 jinkui road, futian free; shenzhen, guangdong, shenzhen, guangdong 51803 8; CH 518038
• MDR Report Key: 11271137
• MDR Text Key: 230023744
• Report Number: 3014148220-2021-00279
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: L540-15120
• Device Lot Number: 4011182008
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other