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

Model Number 7312

Device Problems Material Rupture (1546); Failure to Advance (2524)

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

Event Date 09/30/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, the device unable to cross the lesion and the balloon ruptured due to calcification.The device was completely removed from the patient and the procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.At 13.8cm from the strain relief, the hypotube was kinked.There was contrast present in the inflation lumen.At 117.8cm from the strain relief the shaft and hypotube were kinked at the rapid port exchange.The balloon was tightly folded, and the tip of the device was damaged.The balloon catheter was prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated and maintained pressure as well as deflated with no issue.There were unreported damages to the device such as hypotube and shaft kinks and tip damage.Both damages found are consistent to preventing the device from further crossing the lesion.

Event Description

It was reported that balloon rupture occurred.The 92% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, the device unable to cross the lesion and the balloon ruptured due to calcification.The device was completely removed from the patient and the procedure was completed with another of same device.No patient complications were reported.

• 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: 12603742
• MDR Text Key: 276151319
• Report Number: 2134265-2021-12677
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0026259862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• 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: 81 YR
• Patient Sex: Male