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

Catalog Number L54015120

Device Problems Break (1069); Material Rupture (1546); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Based on above investigation, there are no signs of manufacturing defects from this lot of products.There is no systemic trend identified with regard to this type of event.In this case jade pta 1.5 x 120mm balloon catheter was utilized in an extremely tight (100% stenosis) and heavily calcified lesion.The product was advanced, inflated and deflated (even ruptured at fifth inflation at 20atm) into calcified lesion in the anterior tibial artery.From the case description, it appears that the product was torn off when withdrawing catheter out.If the catheter got caught in the calcified lesion and attempting to remove the product with a force, the balloon material was most likely stretched and cut resulting in a separation from the catheter.In ifu, this kind of failure was foreseeably warned: "if resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breaking or balloon separation." in this case we simulated the failure mode out when we clamped the distal part of balloon by external force in the lab, it did not mean this will be definitely happened in the lesion.Because we cannot precisely figure out the exact location that the balloon was trapped.However, it is the position where the balloon catheter was most likely separated after being trapped.No corrective action is required at this time.There is no evidence of a product malfunction, inadequacy in the ifu and or a manufacturing defect.

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 datils 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
• Manufacturer Contact: samantha chan ; no.1 jinkui road, futian free; shenzhen, guangdong, shenzhen, guangdong 51803-8, ; CH 518038,
• MDR Report Key: 11271138
• MDR Text Key: 231112247
• Report Number: 3003775186-2021-00279
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202231
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L54015120
• Device Lot Number: 4011182008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/03/2021
• 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