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

Model Number 7313

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that balloon deflation issue occurred.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation in a percutaneous coronary intervention (pci).However, the balloon was unable to deflate completely after inflation.No patient complications and injuries were reported, and the patient was stable post procedure.

Event Description

It was reported that balloon deflation issue occurred.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation in a percutaneous coronary intervention (pci).However, the balloon was unable to deflate completely after inflation.No patient complications and injuries were reported, and the patient was stable post procedure.It was further reported that the 70% stenosed target lesion was located in mildly tortuous and non-calcified left anterior descending artery.The balloon was inflated at 12 atmospheres for 5 seconds during dilatation.Negative pressure was applied to the balloon as much as possible before the partially inflated balloon was removed as usual, taking a few seconds.The patient had no symptoms while the device remained inflated.The procedure was completed with another of same device.

• 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 CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15591239
• MDR Text Key: 303626675
• Report Number: 2124215-2022-40346
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0029767255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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