MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SCOREFLEX NC; SCOREFLEX NC SCORING PTCA CATHETER

Catalog Number 625-154-1J

Device Problems Difficult to Remove (1528); Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

The complaint product, scoreflex nc balloon catheter 2.5 x 15mm, was returned for evaluation.Per gross examination, the balloon was inflated and dried blood could be observed on the returned device.The returned balloon catheter was found fractured on pulling wire and formed a v-shape hook on the balloon subassembly.The fracture point is located in the proximal marker band, which is consistent with the laser welding joint.Microscope examination appeared "flat" and "crystallized" fracture face and no necking was found.The fracture visual/appearance is consistent with the brittle fracture characteristics.A penetrating scar was found on the cross section of the fracture point.The case video will be reviewed by our consultant dr.(b)(6).The device history record for the lot number has been reviewed.All the process parameters of laser welding marker band to pulling wire were in compliance with the validated parameters.No issues or discrepancies were noted during this review that would have contributed to the reported event.No other similar complaints were received from the scoreflex nc products up to now.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.In order to further investigate the raw material of scoreflex nc pulling wire/marker band subassembly, a sample of scoreflex nc product was taken out from production line to perform bending and tensile tests.The test results met the product specifications.5.0 conclusion.From the case report and the failure characteristics of the returned product, one possible scenario for this complaint is that the pulling wire of the balloon catheter was accidently broken in tortuous blood vessel and formed a v-shape hook on the balloon subassembly during the procedure, resulting in the balloon catheter hang in the blood vessel and difficult to remove.As once the pulling wire is subjected to high temperature, its toughness will be significantly reduced, it was speculated that fracture was caused by the reduction of the toughness of the pulling wire after being subjected to high temperature, such as high temperature laser irradiation.This is the first time that we have received this kind of product failure and no issues or discrepancies were noted during the review of manufacturing process records, this case is considered to be an individual case.Considering the high risk of this kind of product failure, the preventive actions were issued to avoid the similar case.The actions included: add precautions for laser welding.Retrain relevant operators.Monitoring the tensile failure mode of marker band welding.We will keep the complaint on file for future statistical analysis and trend monitoring.

Event Description

The device will be returned for investigation.(but the cut hub part was not returned.) response letter is required.Event term: difficult to remove.Treated lesion: rca#2-3, 100% stenosed, m calcified, m tortuous.Treatment of rca #2-3 was performed with both antegrade and retrograde approaches.Following the treatment with antegrade approach, the product was used as anchor balloon (12atm) after passing sion through lcx for retrograde wire crossing.After that, guide wires and microcatheters were changed multiple times to pass through to #4pd.In addition, after treatment was performed with ultimate bross3, gaia next2, sion black, gladius ex, and gaia next 4, the physician tried to pull out the product he was using for anchor, but he couldn't pull it out.At this time, the balloon of the product appeared to be bent on fluoroscopy, and when confirmed by ivus, hematoma was formed in the lmt, so the physician had no choice but cut the hub of the product and tried to collect it using guide plus ii 6fr, but he couldn't remove it.Eventually, the patient was sent to surgery for the balloon removal and cabg.The physician commented about this event, "the balloon behavior of the product was clearly strange when it was tried to be removed, so i think the cause of the event was or could be a product defect.I want you to analyze the cause of the problem.".

• Brand Name: SCOREFLEX NC
• Type of Device: SCOREFLEX NC SCORING PTCA CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen, shenzhen 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen guangdong, shenzhen guangdong 51803 8; CH 518038
• Manufacturer Contact: samantha chan ; no.1st jinkui road; futian free trade zone; shenzhen guangdong, shenzhen guangdong 51803-8 ; CH 518038
• MDR Report Key: 14247640
• MDR Text Key: 290442186
• Report Number: 3003775186-2022-04672
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P200041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 625-154-1J
• Device Lot Number: 3618092107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other