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); Detachment of Device or Device Component (2907)

Patient Problems Embolism (1829); Stenosis (2263); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 04/24/2020

Event Type  Injury  

Event Description

It was reported that a balloon rupture occurred resulting in removal difficulty, device fracture, no flow, and subsequent bypass surgery. The patient presented with chest pain. Vascular access was obtained via the radial artery. The non-totally occluded, concentric target lesion was located in a non-tortuous and severely calcified left anterior descending artery (lad). A 2. 5 x 10mm wolverine cutting balloon was used for plaque modification before the 3. 0 x 12mm nc emerge balloon catheter was advanced to treat the target lesion. On inflation up to 30 atmospheres, the balloon ruptured and when the physician tried to remove the device, significant resistance was encountered. After several removal attempts, only part of the balloon was removed and a dissection was noted where the balloon had been earlier. The physician attempted to rewire the vessel but was unable to do so due to the dissection. Angiogram revealed a balloon marker was lodged distally. As there was now no flow in the lad, a surgeon was called and the patient underwent coronary artery bypass graft (cabg). The patient was recovering well in stable condition.

• 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: 10111541
• MDR Text Key: 193417965
• Report Number: 2134265-2020-06369
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/09/2021
• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0024573755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/02/2020 Patient Sequence Number: 1