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

Catalog Number	595015022
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A previously stented superficial femoral artery (sfa) was not calcified as it was stented.An abbott whisper wire was advanced, and laser treatment was performed.An abbott armada balloon was advanced and inflated to an unknown atmospheric pressure but ruptured.A jade balloon was advanced and inflated to 14 atm pressure and ruptured.During an attempt to remove the jade balloon, the jade balloon catheter fractured when it reached the proximal part of the stent.The shaft and half of the jade balloon was removed but the distal part of the jade balloon remained in vivo but was still on the guide wire.While trying to retrieve the distal part of the jade balloon, the wire was accidentally pulled out of position, leaving the distal part of the balloon in vivo.Attempts to rewire the sfa with a whisper wire, viper wire, astato wire were all unsuccessful.The distal part of the jade balloon was left in vivo.The procedure was deemed completed and the patient was stable.It is reported there was no complication.

• 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: 20045413
• Report Number: 3003775186-2024-00304
• Device Sequence Number: 15437158
• Product Code: LIT
• UDI-Device Identifier: 06934955903786
• UDI-Public: (01)06934955903786(11)231111(17)251111(10)5955392310
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/22/2024

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: 595015022
• Device Lot Number: 5955392310
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/23/2024
• 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 Age: 50 YR
• Patient Sex: Male