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

Model Number	1012448-12
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.The reported patient effects of vascular dissection and obstruction/occlusion are listed in the nc trek ifu as known patient effects.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported unexpected medical intervention appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of vascular dissection and obstruction/occlusion and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during device preparation, the 2.75x12mm nc trek balloon dilatation catheter (bdc) was not soaked prior to use.The patient presented with coronary heart disease and underwent a coronary intervention.The procedure was to treat a mildly calcified, mildly tortuous, 90% stenosed lesion in the left anterior descending (lad) artery.The bdc was advanced to post-dilate the vessel and was inflated one time to 16 atmospheres (atm) when the balloon ruptured resulting in a coronary dissection which caused a distal blood flow obstruction.An unspecified stent was implanted to cover the dissection and restore the distal blood flow, and another 2.75x12mm nc trek bdc successfully completed post-dilatation of the vessel.There was no adverse patient sequela.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
• 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: 15577577
• Report Number: 2024168-2022-10504
• Device Sequence Number: 7367870
• Product Code: LOX
• UDI-Device Identifier: 08717648151811
• UDI-Public: 08717648151811
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 1012448-12
• Device Catalogue Number: 1012448-12
• Device Lot Number: 11208G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown