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

Model Number 7313

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that foreign material was found in the device.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, it was noted that a foreign object was stuck at the tip end inside the tube.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that foreign material was found in the device.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, it was noted that a foreign object was stuck at the tip end inside the tube.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the wire was unable to advance due to an obstruction with the device and that there was no object within the device that was not part of the device.

Manufacturer Narrative

Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.At 3mm distal from the bicomponent weld, for a length of 3mm, the guidewire lumen was buckled, prolapsed, punctured, and stretched.Product analysis confirmed the reported events as the guidewire lumen was buckled, prolapsed, punctured, and stretched.

• 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: 17651100
• MDR Text Key: 322291272
• Report Number: 2124215-2023-44472
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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: 0031250537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG