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

Model Number 7213

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 12/22/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The patient was presented with cardiovascular artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in moderate to severely calcified and tortuous left anterior descending artery (lad) as well as radial artery.A 3.75mm x 12mm, 3.75mm x 20mm, 3.75mm x 12mm, and 3.75mm x 15mm nc emerge balloon catheters were used.However, the shaft of the four catheters were badly bent and broken.The devices were both pulled out intact from the patient's body.The procedure was completed different balloon.There were no patient complications reported.

Event Description

It was reported that shaft break occurred.The patient was presented with cardiovascular artery disease and underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in moderate to severely calcified and tortuous left anterior descending artery (lad) as well as radial artery.A 3.75mm x 12mm, 3.75mm x 20mm, 3.75mm x 12mm, and 3.75mm x 15mm nc emerge balloon catheters were used.However, the shaft of the four catheters were badly bent and broken.The devices were both pulled out intact from the patient's body.The procedure was completed different balloon.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 24.7cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There were numerous kinks to the hypotube.There was contrast in the inflation lumen and blood in the guidewire lumen.There was blood within the tight folds of the tightly folded balloon.Product analysis confirmed the reported events as there was separation and kinks to the hypotube of the 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16090912
• MDR Text Key: 306683931
• Report Number: 2124215-2022-55786
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846550
• UDI-Public: 08714729846550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0029358714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2022
• 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