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

Model Number H7493919320300

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

Patient Problem ST Segment Elevation (2059)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.  (b)(4).

Event Description

Same case as mdr id: 2134265-2018-04545 and 2134265-2018-04546.It was reported that st elevation occurred.The target lesion was located in the proximal to the mid right coronary artery.After rotablation was performed, a non-bsc guide wire crossed the lesion and a 3.00mm x 20mm emerge¿ balloon catheter was advanced for dilatation.On inflation of the balloon, st elevations were noted in the avl (augmented voltage left arm) lead.Upon deployment of a 3.0 x 8 synergy stent, more general st elevations were noted, as well as slow flow in the artery.Atropine and adrenaline were initiated, along with a bolus of glyceryl trinitrate.A 3.5 x 16 synergy stent was then deployed and post dilation was performed with a 4.0 non-bsc non-compliant balloon catheter.Following post dilation, st elevation was resolved.The patient recovered well and stayed as an in-patient at the hospital.A second diagnostic catheterization was performed five days later to follow-up and the stents are well deployed and flow issues fully resolved.

• Brand Name: 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: 7498041
• MDR Text Key: 107708181
• Report Number: 2134265-2018-04544
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K113220
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Model Number: H7493919320300
• Device Catalogue Number: 39193-2030
• Device Lot Number: 21399981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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
• Treatment: ABBOTT WIGGLE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention