MAUDE Adverse Event Report: ORBUSNEICH MEDICAL CO. LTD JADE; JADE PTA BALLOON DILATATION CATHETER

Catalog Number L540 50240

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); Foreign Body In Patient (2687)

Event Date 05/20/2021

Event Type  Injury  

Event Description

The device will not be returned for investigation.Response letter is required.Event term: ballon damaged (remained in the body), treated lesion: sfa, 100% stenosed, h calcified, s tortuous.The physician performed pre-dilation of the lesion with the product, placed two eluvia 6.0x120 mm, and then performed post-dilation using the product again.Then the balloon was ruptured and got stuck in the stent placed.The physician was able to solve the stack and remove it from the stent by anterogradely inserting a guiding sheath and then crossing a small-diameter balloon beside the damaged product and expanding it.However, the physician was unable to retrieve the product which was removed from the stent into the guiding sheath, so that having the balloon pulled to the eia, he had no choice but placed the e-luminexx with sandwiching the product, therefore a part of the product remained in the body.Since then, the patient's condition has been stable.The physician commented about this event, "i'm not sure if the cause was a product defect.I want to know (b)(4) view on the causes regarding the balloon rupture and the stacking.".

• Brand Name: JADE
• Type of Device: JADE PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL CO. LTD; 1 jinkui road,; futian free trade zone; shenzhen, shenzhen 51803 8; CH 518038
• MDR Report Key: 12906006
• MDR Text Key: 281508151
• Report Number: 3014148220-2021-04361
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L540 50240
• Device Lot Number: 5300772101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2021
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female