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

Model Number H7493918912250

Device Problem Material Rupture (1546)

Patient Problem Intimal Dissection (1333)

Event Date 12/11/2015

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 vessel dissection occurred.The target lesion was located in the left anterior descending artery.Following predilation using a 2.0x12mm emerge balloon catheter, a 2.50x12mm emerge balloon catheter was advanced to the lesion.The balloon was inflated at 6 atmospheres however at 8 atmospheres, the balloon ruptured.It was then noted that there was vessel dissection.The balloon was removed and the patient was sent for emergency surgery.The balloon was then examined and it was noted that there was a pinhole on the balloon.No further patient complications were reported and the patient's status was fine.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5359548
• MDR Text Key: 35607374
• Report Number: 2134265-2015-09212
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: H7493918912250
• Device Catalogue Number: 39189-1225
• Device Lot Number: 18648871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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: 2.0X12MM EMERGE¿ BALLOON CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR