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

Model Number 7312

Device Problem Break (1069)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A percutaneous coronary intervention was being performed.The 90% stenosed, greater than 30mmx 2.50-3.75mm,concentric, de novo target lesion was located at the moderately tortuous and moderately calcified left anterior descending artery.Following predilation with a 2.00x15mm balloon catheter residual stenosis was 60%.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, it was noted that shaft of the balloon broke into 2 pieces about 20cm from the proximal hub.The procedure was completed with a different device.There was no patient injury reported and the patient status was stable.

Manufacturer Narrative

Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.The hypotube of the device has numerous kinks.There was a hypotube separation 67.2cm from the strain relief.There was contrast in the inflation lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that shaft break occurred.A percutaneous coronary intervention was being performed.The 90% stenosed, greater than 30mmx 2.50-3.75mm,concentric, de novo target lesion was located at the moderately tortuous and moderately calcified left anterior descending artery.Following predilation with a 2.00x15mm balloon catheter residual stenosis was 60%.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, it was noted that shaft of the balloon broke into 2 pieces about 20cm from the proximal hub.The procedure was completed with a different device.There was no patient injury reported and the patient 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12616713
• MDR Text Key: 276381571
• Report Number: 2134265-2021-12764
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0027399079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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 Age: 60 YR
• Patient Sex: Male