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

Model Number 7312

Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969); Material Deformation (2976)

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

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that balloon rupture and removal difficulty occurred, the 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal left anterior descending artery.After a 3.00mm non-boston scientific (non-bsc) stent was implanted, a 5.00mm x 12mm nc emerge balloon catheter was advanced for post-dilation.During inflation at 12 atmospheres, the balloon ruptured.The balloon got stuck in the placed stent and was difficult to remove.A new wire was used as a parallel wire.A non-bsc balloon catheter was advanced on that wire and inflated to remove the emerge.It was noted that something hard could be seen in the balloon catheter part.The procedure was completed with a different device.There was no injury to the patient.

Event Description

It was reported that balloon rupture and removal difficulty occurred, the 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal left anterior descending artery.After a 3.00mm non-boston scientific (non-bsc) stent was implanted, a 5.00mm x 12mm nc emerge balloon catheter was advanced for post-dilation.During inflation at 12 atmospheres, the balloon ruptured.The balloon got stuck in the placed stent and was difficult to remove.A new wire was used as a parallel wire.A non-bsc balloon catheter was advanced on that wire and inflated to remove the emerge.It was noted that something hard could be seen in the balloon catheter part.The procedure was completed with a different device.There was no injury to the patient.

Manufacturer Narrative

Returned product consisted of an nc emerge balloon catheter and photo media.The device was microscopically and visually examined.There were numerous hypotube kinks to the device.There was contrast and blood present in the manifold, inflation lumen and balloon.There was blood in the guidewire lumen and the balloon folds were loose.At 107.6cm-112cm and 120.4cm-121.9cm from the strain relief, the inflation lumen was stretched down.For a length of 4mm just distal to the rapid port exchange (rpe), the shaft, both inflation lumen and guidewire lumen, were stretched down.There was no indication that foreign material (fm) was detected or present.The device was then soaked for a period of time to break up blood and contrast present within the device so further analysis could be completed.Further analysis of the device depicted no fm present.However, where the stretched down inflation lumen segments were, there were longitudinal tears of the same length.R&d engineering reviewed the device due to the reported foreign material (fm) and confirmed no evidence suggesting foreign materials were present within the device.The necked (stretched) down shaft just distal to the rpe would prevent anything from exiting the device.Given the nature of the tears, it was not confirmed if the shaft burst or if the lumen was torn upon device removal.The device could not be inflated for further testing of the balloon to confirm a balloon burst nor was damage to the balloon detected after soaking.No liquid was released from the balloon while it was being compressed to determine if a leak is present.Photo media was reviewed and no balloon damages were detected.A full device photo showed the kinks reported in the complaint which also reflect the kink damage found in analysis.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13945298
• MDR Text Key: 288171239
• Report Number: 2134265-2022-03627
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0026580770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2021
• 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 Outcome(s): Required Intervention