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

Model Number H7493926712400

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2018

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 balloon detachment occurred.The target lesion was located in the ostial right coronary artery.After a guide wire was placed, predilation was performed and stent implantation, a 4.00 mm x 12 mm nc emerge® balloon catheter was advanced for post dilation.The first inflation was successfully done.However, during the second inflation at 18 atmospheres, the balloon ruptured.Upon removal, the balloon material separated from the inner shaft.Follow-up angiogram was immediately done and they re-wired it.The balloon material did not appear to be ¿snare-able¿, it moved distally from the stented area and to stabilize the material it was stented.The patient was informed that there is a remaining foreign body in between the stent.No further patient complications were reported and the patient was doing fine and stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The balloon, proximal bond and markerbands were examined.The inner shaft was separated at the bi-component weld.The separated end was stretched and jagged, indicating the separation was due to tensile overload.The inner shaft was stretched and necked down distal of the guidewire exit notch.The balloon was torn circumferentially in the center of the balloon.The outer shaft was stretched proximal of the proximal balloon weld.The distal section of the device which includes the inner shaft, portion of the balloon, markerbands and tip were 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.There is no indication the device was inflated over rated burst pressure (rbp).The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the ostial right coronary artery.After a guide wire was placed, predilation was performed and stent implantation, a 4.00mm x 12mm nc emerge balloon catheter was advanced for post dilation.The first inflation was successfully done.However, during the second inflation at 18 atmospheres, the balloon ruptured.Upon removal, the balloon material separated from the inner shaft.Follow-up angiogram was immediately done and they re-wired it.The balloon material did not appear to be ¿snare-able¿, it moved distally from the stented area and to stabilize the material it was stented.The patient was informed that there is a remaining foreign body in between the stent.No further patient complications were reported and the patient was doing fine and stable.

• 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: 7429044
• MDR Text Key: 105412774
• Report Number: 2134265-2018-03070
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: H7493926712400
• Device Catalogue Number: 39267-1240
• Device Lot Number: 0021668993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2018
• 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