MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493926715300

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

It was reported that balloon rupture and tip detachment occurred. The chronic totally occluded (cto) target lesion was located in the calcified proximal left anterior descending (lad) artery. A 3. 00 mm x 15 mm nc emerge® balloon catheter was advanced for dilation. After the balloon was inflated to 30 atmospheres, the balloon ruptured and separated into two pieces. The distal tip of the balloon was left in the proximal lad and no attempt was made to retrieve the detached fragment. The procedure was completed with another nc emerge balloon catheter. No further patient complications were reported and the patient's status was fine. The patient is scheduled for further rotational atherectomy on the cto at a later date.

Manufacturer Narrative

Device evaluated by mfr. : returned product consisted of a nc emerge balloon catheter. There was contrast and blood in the lumen. The balloon, shaft and tip were examined. Examination of the balloon revealed a complete circumferential tear with scratches on the balloon material. Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage. The shaft was separated at the bi-component weld. The inner separation was jagged, which indicates that the separation was due to tensile overload. The distal end of the device was not returned for analysis. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. The nc emerge dfu includes the following indication for use: "do not exceed the rated balloon burst pressure. ¿ the balloon compliance chart in table 2 within the dfu lists 20 atm as the rated burst pressure for 3. 00mm diameter devices. (b)(4).

Event Description

It was reported that balloon rupture and tip detachment occurred. The chronic totally occluded (cto) target lesion was located in the calcified proximal left anterior descending (lad) artery. A 3. 00mm x 15mm nc emerge balloon catheter was advanced for dilation. After the balloon was inflated to 30 atmospheres, the balloon ruptured and separated into two pieces. The distal tip of the balloon was left in the proximal lad and no attempt was made to retrieve the detached fragment. The procedure was completed with another nc emerge balloon catheter. No further patient complications were reported and the patient's status was fine. The patient is scheduled for further rotational atherectomy on the cto at a later date.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7297231
• MDR Text Key: 100973011
• Report Number: 2134265-2018-01275
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/10/2020
• Device Model Number: H7493926715300
• Device Catalogue Number: 39267-1530
• Device Lot Number: 0021589536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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: 02/26/2018 Patient Sequence Number: 1