MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD JADE 14 OTW PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Catalog Number	581524022
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a peripheral procedure to treat 99% diffused stenosed calcified lesion about 2mm-3mm in diameter in right anterior tibial (at) artery via left common femoral approach with a 6 fr 90 cm non-csi abbott sheath, a 1.5mm x 240 mm jade balloon was advanced over a guidewire.The balloon ruptured upon first inflation.Upon removal of the ruptured balloon, it was noticed that the actual balloon had separated off of the delivery catheter and was left in the patient's right at.The physician attempted to retrieve the balloon using a non-csi/abbott snare but was unsuccessful.A second attempt was made via pedal at access approach to retrieve the balloon using a non-csi/abbott snare, which was also unsuccessful.Another 1.5mm x 240mm jade balloon was advanced next to the sheared off balloon in the vessel, in an attempt to inflate and drag the balloon back out of the at, however this was also unsuccessful.After several failed attempts to retrieve the sheared off balloon, the physician decided to leave the balloon in the at.The at was originally occluded at the beginning of the procedure, and hence leaving the balloon in the at did not cause any additional damage and did not block flow, since patient did not have flow to start.The balloon was left in the right at.The physician then treated lesions in posterior tibial (pt) artery after which the patient had pulsatile flow to foot.The popliteal artery and lower superior femoral artery (sfa) were then treated with non- csi/abbott stents.The patient's inflow and outflow were confirmed after a final angiogram.All the devices were then removed closed with a 6f non-csi/abbott closure device in the left common femoral artery.The procedure was delayed and the patient was in stable condition.Background: there were no patient complications.Additional information was received on 2024/7/9: the inflation pressure was not recorded.The fragment was left in the patient's body after unsuccessful attempts to remove it.There was no harm to the patient.

• Brand Name: JADE 14 OTW PTA BALLOON DILATATION CATHETER
• Common Device Name: Catheter, angioplasty, peripheral, transluminal
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: yuki li ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 19718058
• Report Number: 3003775186-2024-00252
• Device Sequence Number: 20905439
• Product Code: LIT
• UDI-Device Identifier: 06934955900754
• UDI-Public: (01)06934955900754(11)230510(17)250510(10)5821402304
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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 Catalogue Number: 581524022
• Device Lot Number: 5821402304
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown