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

Model Number H7493912420250

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2018

Event Type  malfunction  

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 catheter perforation and balloon rupture occurred.The target lesion was located in the right coronary artery.A 20mm x 2.50mm nc quantum apex¿ balloon catheter was selected for dilatation.However, the guide wire exited the balloon side instead of going through the monorail segment and it also ruptured the balloon.The device was removed and the procedure was completed with a different device.No patient complications were reported.

• Brand Name: NC QUANTUM APEX¿
• 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: 7754361
• MDR Text Key: 116154697
• Report Number: 2134265-2018-07084
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• 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
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: H7493912420250
• Device Catalogue Number: 39124-2025
• Device Lot Number: 21225573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• 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