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

Model Number H7493912415250

Device Problems Hole In Material (1293); Inflation Problem (1310)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 06/03/2014

Event Type  Injury  

Event Description

It was reported that shaft perforation, air embolization, st elevation and hypotension occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending (lad) artery.A 15mm x 2.50mm nc quantum apex¿ balloon catheter was selected to dilate the lesion.During preparation, the device was removed from the protective hoop and air evacuation was performed.When the physician applied negative pressure to the inflation lumen there were no issues noted.When applying pressure to inflate the balloon, a hole was noted and the material was flared on the device.The pressure level did not increase.The remained air in the inflation lumen went out from the hole on the device into the coronary artery with contrast media.Saline leakage at the proximal area at around 20 cm from the tip of the distal shaft was found.The physician suspected air entered into the hole on the device when air evacuation was performed and the air remained in the inflation lumen of the device.The patient experienced air embolization, st elevation and decreased blood pressure level.Noradrenaline was administered repeatedly and intravenous injection of atropine was performed.After 15-20 minutes post procedure, the patient recovered.There was no resistance encountered during the procedure.The procedure was completed with a non-bsc device.No further patient complications were reported.One day post procedure, the patient was then discharged.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the nc quantum apex balloon catheter was received for analysis.There was contrast in the inflation lumen.There were multiple shaft kinks.Magnified inspection revealed the core wire protruding through the outer shaft 6cm from the guide wire exit notch.This damage is consistent with the reported leak.Microscopic inspection revealed no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that shaft perforation, air embolization, st elevation and hypotension occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal left anterior descending (lad) artery.A 15mm x 2.50mm nc quantum apex¿ balloon catheter was selected to dilate the lesion.During preparation, the device was removed from the protective hoop and air evacuation was performed.When the physician applied negative pressure to the inflation lumen there were no issues noted.When applying pressure to inflate the balloon, a hole was noted and the material was flared on the device.The pressure level did not increase.The remained air in the inflation lumen went out from the hole on the device into the coronary artery with contrast media.Saline leakage at the proximal area at around 20 cm from the tip of the distal shaft was found.The physician suspected air entered into the hole on the device when air evacuation was performed and the air remained in the inflation lumen of the device.The patient experienced air embolization, st elevation and decreased blood pressure level.Noradrenaline was administered repeatedly and intravenous injection of atropine was performed.After 15-20 minutes post procedure, the patient recovered.There was no resistance encountered during the procedure.The procedure was completed with a non-bsc device.No further patient complications were reported.One day post procedure, the patient was then discharged.

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3897720
• MDR Text Key: 4675575
• Report Number: 2134265-2014-03675
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2016
• Device Model Number: H7493912415250
• Device Catalogue Number: 39124-1525
• Device Lot Number: 16599882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• 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