MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD JADE 18 OTW PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Catalog Number	596024032
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The jade otw.018" 200cm pta balloon was used for treatment of 99% stenosed, heavily calcified, in-stent restenosis (isr) lesion in superficial femoral artery (sfa) via radial access.6fr terumo guiding sheath was in use.The non-csi/non-abbott atherectomy catheter (auryon) had difficulty tracking on the viperwire advance guide wire with flex tip but atherectomy was able to be performed on the isr lesion.There was no allegation of malfunction against the viperwire.The viperwire and non-csi/non-abbott atherectomy catheter were removed.The jade otw balloon was advanced over the asahi minamo workhorse frontline guide wire into the isr and inflated at sixteen atmospheres (atm).The nominal pressure is fourteen atm and the bursting pressure is eighteen atm.During inflation, the patient bent his leg that was being treated.The balloon burst.The burst balloon had three components.The major part was attached to the catheter and was removed along with the second part.Cine angiographic imaging and fluoroscopy revealed the third component remained in the right brachial artery.Mechanical aspiration was attempted via radial access to snare the fractured component but failed.Mechanical aspiration was then attempted via femoral access which also failed.Fogarty technique also failed to retrieve the fractured component.The procedure was aborted, and the patient was sent to hospital for surgical removal of the fractured component.The patient was stable.

• Brand Name: JADE 18 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: 19178419
• Report Number: 3003775186-2024-00178
• Device Sequence Number: 17992779
• Product Code: LIT
• UDI-Device Identifier: 06934955904936
• UDI-Public: (01)06934955904936(11)230607(17)250607(10)5923422305
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202231
• 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): 04/25/2024

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: 596024032
• Device Lot Number: 5923422305
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/25/2024
• 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: Required Intervention
• Patient Sex: Unknown