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

Model Number 7213

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 26-may-2022.It was reported that removal difficulties into the guide catheter and device interaction encountered.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left main artery.After stent deployment, a 6.00mm x 15mm nc emerge balloon catheter was advanced for post dilation.After the balloon was inflated to 12 atmospheres, the device would not come back into the guide.After several attempts of pulling negative and trying to remove the balloon through the guide catheter, the physician pulled negative on the balloon and removed the 6fr guide catheter manually together with the balloon and the wire.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed balloon catheter froze on wire.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter with an unknown guidewire.The device was visually and microscopically examined.The guidewire returned with the device was froze on wire and not removable due to the shaft damage of the device.Removal of the wire would likely cause further damage.There was contrast in the inflation lumen and the balloon.The inflation lumen was stretched for a length of 26.6cm just distal to the midshaft bond.The shaft was stretched down just distal to the rapid port exchange for a length of 4mm.There was blood in the guidewire lumen.At 44mm from the tip of the device, for a length of 3mm, the guidewire lumen was buckled.The balloon was loosely folded, and the tip was damaged and prolapsed.The guidewire was returned within the balloon catheter.The exposed portion of the wire was measured with a laser micrometer to measure the outer diameter which was within compatible use according to the instruction for use (ifu).There was unreported shaft and tip damage to the device that would cause resistance during device advancement or removal.The buckling of the guidewire lumen is indicative to an interaction with the guidewire.

• 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: 14738881
• MDR Text Key: 298303360
• Report Number: 2134265-2022-06162
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846604
• UDI-Public: 08714729846604
• 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
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028408949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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
• Treatment: GUIDEWIRE: ASAHI PROWATER ABBOTT VASCULAR
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White