MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.In the absence of a reported part number, the udi cannot be calculated.(b)(4).The device was not returned for evaluation.It was reported that the balloon was inflated to 20 atmospheres three times.It should be noted the instruction for use, states: balloon pressure should not exceed the rated burst pressure (rbp).A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device and bulky appearance appear to be related to operational context due to the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The 4.5 x 12 mm nc trek is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was performed to treat a lesion with no tortuosity and no significant calcification in the proximal right coronary artery (rca).Post-dilatation was performed with two nc trek balloons.The 4.0 nc trek balloon was inflated 3 times at 20 atmospheres (atm); however, the deflation was very slow.During the attempt to withdraw the catheter, the balloon got stuck at the tip of the guiding catheter.The catheter was able to be removed even though the balloon was bulky.Then, a 4.5 nc trek was used to complete post-dilatation and inflated to 18, 20, 24 atm.This balloon failed to deflate and during the attempt to withdraw the device, the balloon got stuck at the tip of the guiding catheter; therefore, all devices (4.5 x 12 mm nc trek balloon, guide wire and guiding catheter) had to be removed as a single unit.There was no further intervention required after the balloons were removed.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7049338
• MDR Text Key: 93326841
• Report Number: 2024168-2017-09107
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/21/2017
• 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: Initial
• Patient Sequence Number: 1