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

Catalog Number	582524032
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During treatment of an 80%-90% mixed calcified plaque/lesion which was approximately 2.0 mm- 2.5 mm in length, in the distal posterior tibial artery, the jade balloon separated from the catheter on exiting the sheath during the procedure.The balloon was initially inflated at lesion site.There was difficulty to remove the orbital atherectomy device (oad) after balloon deflation.However, the balloon was pulled and eventually removed.After physical inspection and results from angiography showed a part of balloon at the site of inflation and this part of the balloon was left in the leg.Background: received the following additional information on july 25, 2024: 1.When did the problem occur? (during set-up, procedure, or performance testing) - during procedure.2.Could you please provide vessel and lesion details? (vessel, lesion location, % stenosis, level of calcification, diameter, etc.) - distal pt.80%-90% mixed calcified/plaque lesion.Approx.2.0mm-2.5mm diameter.3.Was the balloon inflated during the procedure? - balloon was inflated at lesion site.4.Did the balloon remain intact and completely removed from the body? - after balloon deflation, device was difficult to remove.Balloon was pulled and eventually removed.After physical inspection and angiographically, part of balloon was observed at the site of inflation.5.Was intervention required to remove the balloon completely from the body? - part of balloon was left in the leg.6.How was the procedure completed? - intervention plans are to remove balloon from leg with a smaller snare retrieval device.- after reaching out to the customer the procedure for the snare has not been performed or scheduled.Do not have an anticipated scheduled date.

• 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: 19903963
• Report Number: 3003775186-2023-02475
• Device Sequence Number: 12546890
• Product Code: LIT
• UDI-Device Identifier: 06934955901621
• UDI-Public: (01)06934955901621(11)230714(17)250714(10)5833202307
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 582524032
• Device Lot Number: 5833202307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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