MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7312

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  malfunction  

Event Description

It was reported that catheter entrapment occurred.Vascular access was obtained via radial artery.The 12 x 4.5mm target lesion was an area of in-stent restenosis (isr) located in the moderately tortuous right coronary artery (rca).An opticross imaging catheter was advanced to check the device sizing requirements.After pre-dilatation with a 2.0x15mm non-bsc balloon catheter and treatment with 4.0 x 15mm and 4.0 x 20 drug coated balloon catheters, a 4.5 x 15mm non-bsc balloon catheter was failed to cross for post-dilatation.The device was replaced a 4.50mm x 12mm nc emerge balloon catheter and although there were challenges advancing the catheter, eventually the rca isr was successfully post-dilated.The device was deflated and upon withdrawal, the balloon catheter got stuck with a non-bsc guidewire.Both devices were removed with no additional intervention.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8913512
• MDR Text Key: 155054493
• Report Number: 2134265-2019-09740
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0023931828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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