MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number 1012451-06

Device Problems Leak/Splash (1354); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated.A visual and functional inspection was performed on the returned device and the following was noted: tear and hypotube bends.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.Balloon material tears can be affected by numerous factors such as balloon damage during manufacturing of the balloon material, materials, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The investigation was unable to determine a conclusive cause for the noted balloon tear.It is possible that during advancement the balloon interacted with the anatomy and or other devices used in the procedure caused a tear on the balloon resulting in a leak during attempts to inflate; however, this could not be confirmed.The noted bends on the hypotube likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Abbott vascular received this device without a reported complaint.Upon device investigation, it was noted that the balloon leaked from a tear.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10596950
• MDR Text Key: 208952058
• Report Number: 2024168-2020-08072
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151958
• UDI-Public: 08717648151958
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103153
• 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
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1012451-06
• Device Catalogue Number: 1012451-06
• Device Lot Number: 91111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• 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