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

Model Number UNK651

Device Problem Deflation Problem (1149)

Patient Problem Bradycardia (1751)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).

Event Description

Same case as mdr id: 2134265-2018-05597. It was reported that deflation failure occurred. The procedure was a complex intervention of the left coronary system. The target lesion was located in the 90% stenosis, normal calcification, non tortuos bifurcation of the ramus intermedius artery and the ramus interventricularis anterior artery. At the end of the procedure, the previously implanted stents were post-dilated with a nc quantum apex balloon catheter to achieve optimal results. The nc quantum apex balloon was inflated four times during post-dilation with an encore inflation device to a maximum pressure of 16 bar. Following the fourth inflation the encore inflation device was used to deflate the balloon and the pressure gauge did not respond accordingly. Several attempts were made to deflate the balloon by aspirating the encore syringe. This caused significant delay which resulted in a short term hemodynamic instability; lowering of the blood pressure and bradycardia. The encore inflation device was disconnected from the nc quantum apex balloon, retracted into the guiding catheter and the balloon was removed. There was a "lethal threat to the patient for a short time," but it was very quickly brought under control. The patient was not harmed and there was no consequential damage.

• Brand Name: NC QUANTUM APEX BALLOON CATHETER
• 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: 7579398
• MDR Text Key: 110418732
• Report Number: 2134265-2018-05102
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNK651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/07/2018 Patient Sequence Number: 1