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

Model Number H7493927615250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was not returned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-13351, 2134265-2018-00447 and 2134265-2018-00549.It was reported that vessel dissection occurred.Vascular access was obtained via the right femoral artery using a 6f introducer sheath.The target lesion was located in the mid left anterior descending artery (lad).After a 6f 3.75mm extra back up non-bsc guide catheter was placed in the left main coronary artery, a 182cm choice¿ pt guide wire was advanced in the distal lad.A 15x2.50mm emerge balloon catheter was advanced on the level of the proximal lad to predilate the lesion at 16 atmospheres for 5 seconds.A 28 x 2.50mm promus premier¿ stent was advanced in the proximal lad using a guidezilla guide extension catheter.Another 15x2.75mm emerge balloon catheter was advanced on the level of the proximal lad to predilate the lesion at 18 atmospheres for 25 seconds.The stent could be moved but not completely beyond the stenosis.The stent could not be removed back into the guidezilla and deployment was performed at 15 atmospheres for 4 seconds.The stent delivery balloon failed to completely expand and the promus premier¿ stent was not apposed.The balloon could not be placed back in the catheter and eventually rupture of the shaft of the balloon catheter was noted.Extra ballooning with a 1.0x5mm non-bsc balloon was performed to trap the guidewire along with a piece of the balloon shaft in the catheter and everything from the lad was extracted.A new guide wire was advanced and a 2.5x15mm nc emerge® balloon catheter was advanced to expand the distal edge of the promus premier stent.The balloon was inflated 4 times with a maximum pressure of 16 atmospheres for 12 seconds and a dissection was noted.Another 2.75x15mm nc emerge balloon was advanced and inflated at 24 atmospheres for 40 seconds but could not completely expand the promus premier¿ stent.Flow was maintained in the lad and there were no electrocardiography (ecg) deviations.The patient was sent to the operating room in stable condition for coronary artery bypass grafting of the left internal mammary artery to the lad and vene on the right coronary artery.

• 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: 7202272
• MDR Text Key: 97631170
• Report Number: 2134265-2017-13250
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: H7493927615250
• Device Catalogue Number: 39276-1525
• Device Lot Number: 19273219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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
• Patient Age: 78 YR
• Patient Weight: 70