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

Model Number	1012452-15
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 incidents from this lot.It should be noted that the nc trek rx coronary dilatation catheter instructions for use (ifu) states: caution: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.It is undetermined if the deviation of the ifu caused/contributed to the reported material rupture.It is possible that interactions with the anatomy/other devices and/or the deviation of the instructions for use resulted in the reported material rupture; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the right coronary artery (rca).A 3.75x15mm nc trek balloon dilatation catheter (bdc) was prepped (air aspirated) while inside the patient anatomy.The bdc was then advanced without resistance to the target lesion.The balloon was inflated once; however, it ruptured below rate of burst pressure at 12 atmospheres.The bdc was removed without issue.The procedure was successfully completed with another same size nc trek bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10820664
• Report Number: 2024168-2020-09403
• Device Sequence Number: 17083687
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: 08717648152030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1012452-15
• Device Catalogue Number: 1012452-15
• Device Lot Number: 90523G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1