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

Model Number 1012452-20

Device Problem Material Rupture (1546)

Patient Problems Air Embolism (1697); Ventricular Tachycardia (2132)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a mildly calcified lesion in the proximal left anterior descending artery.A 3.75x20mm nc trek rx balloon dilatation catheter (bdc) was being used to post-dilate a 3.5mm non-abbott stent; however, the balloon ruptured at about 4-6 atmospheres.Several small air bubbles escaped into the vessel.The patient then experienced ventricular tachycardia (not-sustained or requiring shock) and it resolved quickly.The balloon was removed intact without further incident.The procedure was completed with successful post-dilatation of the stent with a new 3.75x20mm nc trek bdc.The patient is fine and well today.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported balloon rupture was unable to be confirmed; however, the noted tear in the outer member is what likely was perceived as the rupture by the account.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.The investigation determined the reported complaint appears to be related to operational context as return analysis noted that the support mandrel punctured and tore through the outer member proximal to the guide wire exit notch.In this case, it is likely that the device interacted with an accessory device and/or was inadvertently mishandled during advancement such that the outer member and skive/bayonet were kinked resulting in the support mandrel puncturing and tearing through the outer member and subsequently leaking, giving the impression of a rupture.The reported patient effect of air embolism is listed in the coronary dilatation catheters nc trek rx, global, instruction for use as a known patient effect.A conclusive cause for the reported patient effects of air embolism and ventricular tachycardia and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9411439
• MDR Text Key: 169136074
• Report Number: 2024168-2019-14118
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152047
• UDI-Public: 08717648152047
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1012452-20
• Device Catalogue Number: 1012452-20
• Device Lot Number: 90708G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.5MM ORSIRO STENT; 3.5MM ORSIRO STENT
• Patient Outcome(s): Other
• Patient Age: 80 YR