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

Model Number H7493912415350

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon rupture and balloon detachment occurred.The target vessel was located in the ostium of the right coronary artery (rca).A 15mm x 3.50mm nc quantum apex¿ balloon was used in an attempt to deploy a poorly deployed stent that was placed during an earlier procedure.During the initial inflation at 28 atmospheres, the balloon ruptured.When retrieving the balloon catheter, some resistance was felt but not much more than expected when inflating at such a high pressure.Afterwards, it was noted on angiogram that something was in the proximal rca and the tip of the balloon was missing.The detached fragment migrated into the mid rca and got stuck in stenosis.A stent was deployed to cover the detached balloon fragment.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter without the distal portion of the balloon, markerbands, inner shaft or tip.The outer shaft, and inner shaft were microscopically examined.The distal portion of the balloon, inner shaft, markerbands and tip were not returned for analysis.The balloon is completely circumferentially torn 10mm from the proximal balloon waist.The inner shaft is completely separated/torn 5mm from the exit notch.The fractured/separated end of the shaft was stretched and jagged which indicates the shaft separation was due to tensile forces.There are numerous hypotube and shaft kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.It was reported that the balloon was inflated to 28 atmospheres.The rated burst pressure of the complaint device is 20 atmospheres.The nc quantum apex directions for use includes the following warning: catheter placement and removal ¿ do not exceed the balloon rated burst pressure.(b)(4).

Event Description

It was reported that balloon rupture and balloon detachment occurred.The target vessel was located in the ostium of the right coronary artery (rca).A 15mm x 3.50mm nc quantum apex¿ balloon was used in an attempt to deploy a poorly deployed stent that was placed during an earlier procedure.During the initial inflation at 28 atmospheres, the balloon ruptured.When retrieving the balloon catheter, some resistance was felt but not much more than expected when inflating at such a high pressure.Afterwards, it was noted on angiogram that something was in the proximal rca and the tip of the balloon was missing.The detached fragment migrated into the mid rca and got stuck in stenosis.A stent was deployed to cover the detached balloon fragment.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• 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: 7541889
• MDR Text Key: 109172571
• Report Number: 2134265-2018-04470
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121667
• 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,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: H7493912415350
• Device Catalogue Number: 39124-1535
• Device Lot Number: 21776705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• 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