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

Model Number H7493926712250

Device Problem Material Rupture (1546)

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 vessel perforation, cardiac tamponade and balloon rupture occurred.A 2.50mm x 12mm nc emerge® balloon catheter ruptured and caused a coronary perforation.It was also noted that the patient had cardiac tamponade.The procedure was completed with a different device.No further patient complications were reported and the patient is fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.The balloon was loosely folded.There is tip damage.There is blood in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.There is a 7mm long tear/perforation in the outer shaft 6mm from the bi-component weld.The balloon is bunched-up.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that vessel perforation, cardiac tamponade and balloon rupture occurred.A 2.50mm x 12mm nc emerge balloon catheter ruptured and caused a coronary perforation.It was also noted that the patient had cardiac tamponade.The procedure was completed with a different device.No further patient complications were reported and the patient is fine.

• 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: 6876409
• MDR Text Key: 86618967
• Report Number: 2134265-2017-09266
• Device Sequence Number: 1
• Product Code: LOX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2019
• Device Model Number: H7493926712250
• Device Catalogue Number: 39267-1225
• Device Lot Number: 20869223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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