MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD JADE 35 OTW PTA BALLOON DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Catalog Number 606010022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2023

Event Type  Injury  

Manufacturer Narrative

This adverse event was reported in esg test system on 2023/04/25 (mfr report #: 3003775186-2023-00703).Since we realize it is not correct to report it in the test system, we now take the corrective action to submit this report in the production system.This adverse event is an individual case and per our investigation, it is concluded that there is no evidence of a product malfunction, inadequacy in the ifu, or a manufacturing defect regarding this event.We have taken corrective and preventive actions in our company to correct the wrong reporting issue and prevent this issue from re-occurring in the future.

Event Description

1.0 complaint description: a jade balloon burst between twenty and twenty-two atmospheres and became stuck on a newly implanted stent in the arteriovenous (av) fistula.The balloon fractured inside the av grand and pieces were unable to be retrieved.An artery compression device was placed on site.The patient was stable.According to the physician, the event was due to patient anatomy.2.0 background: there were patient complications: the balloon fractured inside the av grand and pieces were unable to be retrieved.The patient was stable.Patient information: 63 years, male.Target lesion information: a newly implanted stent in the arteriovenous (av) fistula.Inflation pressure: 20~22 atm.Associated device: 6f cook ansel sheath, 0.035 glide wire, 7x60 medtronic self-expanding stent.No case image/cd was provided for analysis.The additional information obtained through email is as follows: q1.It was mentioned that the balloon burst at 24atm and that the balloon was inflated beyond rate of burst pressure (20-24atm).Can you please confirm when the balloon burst and if it was within inflation parameters? answer: after more discussion with tech, the balloon burst around 20-22 atm.24 was never reached.Q2.Does the physician allege a malfunction on the balloon? answer: no, he felt it was more the anatomy pushing the limits of the balloon.Q3.How large was the fragment that was left in the patient? answer: it was about half the balloon material with the distal portion of the balloon shaft where the distal marker is that was left behind.Q4.Does the physician have any concerns about potential long-term risks/outcomes? answer: he did not.It was a "last ditch effort" to save the fistula.Felt the balloon piece left behind was in the venous side of the fistula and was not flow restricted, thus would not be an issue.Q5.What other devices and wires were used during the procedure? (brands, types, sizes, etc.) answer: 7x60 medtronic self-expanding stent,.035 glide wire, 5x60 jade, 6f cook ansel sheath, snare (unsure of brand).Q6.Patient lesion information? answer: severe fibrotic in-stent restenosis.3.0 facts of investigation: a review of the complaint clinical information indicated that a jade 35 otw balloon burst between twenty and twenty-two atmospheres and became stuck on a newly implanted stent in the arteriovenous (av) fistula.The balloon fractured inside the av grand and pieces were unable to be retrieved.An artery compression device was placed on site.In product ifu this kind of failure was foreseeably warned: "balloon pressure should not exceed the rated burst pressure (18 atm)." since neither the involved device nor the cd of the procedure was provided for evaluation, the investigation was limited to the review of our facility quality records.The device history record for this lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.During the manufacturing processes each catheter is inflated to its rated burst pressure (18atm) to check for leaks prior to release.No other similar complaints have been received from this lot up to now.4.0 conclusion based on the statistical process control (spc) review, all balloons burst values and bonding tensile strength of jade 35 otw balloon catheter were over the lower control limit (lcl) and remaining stable, implying that the balloon forming and bonding processes are in compliance with the product specifications and under control.Orbusneich medical manufacturing processes include extensive testing and inspections to ensure each product meets all material, assembly, and performance specifications prior to release.After the analysis of above information, the type of this complaint is determined as balloon detachment.Based on the above investigation, there are no signs of manufacturing defects from this lot of products.There is no systemic trend identified with regards to this type of event.Factors that can contribute to balloon rupture include, but are not limited to, material, interaction with other devices, patient anatomy, lesion calcification, tortuosity or balloon inflation pressure and time.From the case information, it was likely that unique patient lesion morphology contributed to this incident.However, details could not be ascertained as the device was not returned for analysis and the clinical situation could not be fully duplicated in our analysis lab.This complaint has been shared with the manufacturing and engineering teams.We will keep the complaint on file for future statistical analysis and monitoring.No corrective action is required at this time.There is no evidence of a product malfunction, inadequacy in the ifu, or a manufacturing defect.The complaint and analysis will be included in the complaint data reviewed and monitored for this product.

• Brand Name: JADE 35 OTW PTA BALLOON DILATATION CATHETER
• Type of Device: 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: air xu ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-8 ; CH 518038
• MDR Report Key: 18947228
• MDR Text Key: 338186158
• Report Number: 3003775186-2023-00703
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/03/2024
• Device Catalogue Number: 606010022
• Device Lot Number: 6011212209
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Date Device Manufactured: 03/03/2022
• 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; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male