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

Catalog Number	622-204-1U
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A scoreflex nc scoring balloon was used for treatment of a heavily calcified, 85% stenosed lesion in mid left anterior descending (lad) artery via right radial approach.A 6fr guiding catheter was used to deploy the balloon to the lesion.No resistance was felt while advancing the balloon.The scoreflex was inflated at nominal pressure in mid lad artery totally occluding it.The scoreflex could not be deflated.Using different indeflators, syringes and other unspecified devices did not resolve the issue.Wire cutters from the operating room (or) were used to cut the balloon shaft at the hub to get it to deflate but the balloon remained inflated.A guide extension catheter was placed over the cut shaft to wedge the balloon down as much as possible.With some gentle pulling, they were able to get the balloon to the guide extension catheter and pulled the whole system out together.The use of the guide extension catheter was unplanned and reactive to the balloon not deflating.The balloon remained inflated hours later despite the cut shaft.To complete the procedure, balloon angioplasty and stent placement were performed using abbott bmw guide wire for device delivery.There was a three-minute delay to the procedure but no harm to the patient.While picking up the balloon for product return, the abbott sales representative observed a mid-distal kink in the shaft of the balloon.It is unknown when the kink occurred.Background: target lesion information: heavily calcified, 85% stenosed, mid lad there were patient complications: scoreflex balloon totally occluded mid lad artery, causing no blood flow.Patient status: satisfactory patient information: 68 years old, male inflation pressure: nominal(12 atm) associated product: 6fr cordis guiding catheter, abbott bmw guide wire no case image/cd was provided for analysis.Additional information were received via e-mail on 2024/7/9: q1: abbott sales representative observed a mid-distal kink in the shaft of the balloon, can i confirm the position of the kink? -no, can not confirm q2: what ratio of contrast medium and saline was used during the procedure?-50\50 q3.Since only the distal portion of the balloon catheter was returned for analysis, can i know if the proximal part has been collected and if it can also be returned for analysis? -no.

• 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: 19718052
• Report Number: 3003775186-2024-00234
• Device Sequence Number: 12834656
• Product Code: NWX
• UDI-Device Identifier: 06934955936333
• UDI-Public: (01)06934955936333(11)230204(17)250204(10)3600562301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: 622-204-1U
• Device Lot Number: 3600562301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/11/2024
• 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 Age: 68 YR
• Patient Sex: Male