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

Model Number H7493808012270

Device Problems Material Rupture (1546); Material Deformation (2976)

Patient Problem Intimal Dissection (1333)

Event Date 01/11/2018

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 balloon rupture, shaft inflation and vessel dissection occurred. The target lesion was located in the left anterior descending artery. A 2. 75mm x 12mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion. However, upon inflation the balloon ruptured in the stent and vessel dissection was noted. The device was removed from the patient. It was then noted that the balloon shaft inflated. Another bsc balloon was used to treat the dissection and the procedure was completed. No further patient complications were reported and the patient's status was stable.

• Brand Name: QUANTUM¿ MAVERICK¿
• 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: 7211391
• MDR Text Key: 97944541
• Report Number: 2134265-2018-00433
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/12/2020
• Device Model Number: H7493808012270
• Device Catalogue Number: 38080-1227
• Device Lot Number: 0021382763
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/22/2018 Patient Sequence Number: 1