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

Model Number 7313

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 94% stenosed target lesion was located in moderately tortuous and severely calcified mid left anterior descending artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during inflation the balloon burst.Kink was also noticed due to angulation when crossing the lesion.The procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable.

Event Description

It was reported that balloon rupture occurred.The 94% stenosed target lesion was located in moderately tortuous and severely calcified mid left anterior descending artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during inflation the balloon burst.Kink was also noticed due to angulation when crossing the lesion.The procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There were numerous hypotube kinks to the device.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon.The balloon was loosely folded.There was a 6mm longitudinal shaft tear 5mm proximal to the proximal balloon waist.Product analysis confirmed the reported events, as the device was found to have a longitudinal shaft tear and numerous kinks to the hypotube.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16916152
• MDR Text Key: 315068375
• Report Number: 2124215-2023-23486
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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: 0030472135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male