MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SCOREFLEX NC SCORING PTCA CATHETER; Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Catalog Number	617-104-1U
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We got aware of this case (our internal reference no.Is (b)(4)) on 2024/3/30 and made a not reportable decision after our analysis of the complaint description.Then we received two medical device user reports mw5153514 & mw5153515 concerning this case from fda on 2024/4/11.After several communications with our customer abbott to check and to try to get additional information later, we still did not get the other more information than we received at first.Since there is no sign of reporting and there is no patient complication from our re-analysis of the case, we then made the second not reportable decision after.After that, we received the returned product of this case on 2024/5/2 and found that the tip of the returned product was fractured and missing, we cannot make sure where the missing tip is, on the principle of reporting when suspicious, we report this case out of an abundance of caution.
Event or Problem Description
Multiple non-csi/non-abbott balloons were attempted to be used in a super tight proximal left anterior descending artery (lad) lesion, however, the balloons ruptured.A scoreflex balloon was attempted to be used in the lad when it backed the guide up and the wire loop was behind the short rapid exchange catheter.The physician proceeded to pull the balloon with the loop and the balloon came off of the wire.The entire wire and teleflex guideliner were pulled out of the patient.It appeared that the rapid exchange catheter may have split, but this was unable to be confirmed.The guideliner was flushed and the physician re-wired with a new wire to complete the procedure.Background: a super tight proximal left anterior descending artery (lad) lesion.It was reported as no patient complications.

• Brand Name: SCOREFLEX NC SCORING PTCA CATHETER
• Common Device Name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
• 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: 19318156
• Report Number: 3003775186-2024-00156
• Device Sequence Number: 7648697
• Product Code: NWX
• UDI-Device Identifier: 06934955936258
• UDI-Public: (01)06934955936258(11)220912(17)240912(10)3624952208
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P200041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: 617-104-1U
• Device Lot Number: 3624952208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2024
• Initial Report FDA Received Date: 05/15/2024
• 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