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

Catalog Number 1012449-15

Device Problem Material Separation (1562)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolism (1829); Occlusion (1984); No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during the intervention, a piece of the balloon shaft may have separated and a stent may have been implanted to stabilize the separated portion.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.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 from this lot.The reported patient effects of occlusion and embolism are listed in the nc trek rx coronary dilatation catheter instructions for use (ifu) as known patient effects of coronary procedures.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction of devices/anatomy and/or inadvertent mishandling resulted in the reported/noted inner and outer member material separation.The reported difficulties possibly caused/contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3: date of event e1, e3: initial reporter.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was provided: it was reported that on (b)(6) 2020 the patient presented for a mid left anterior descending (lad) to distal left main intervention.Slow flow through the distal lad was noted.There was noted transient ecg changes and a small apical myocardial infarction was noted, but the patient remained hemodynamically stable.An intra-aortic balloon pump was placed and the 3x15 nc trek was advanced into the vessel and inflated to 15 atmospheres (atm) for 20 seconds, then 18 atm for 12 seconds.During balloon deflation it was observed that the distal balloon portion of the shaft separated but remained in the lad.Several unsuccessful attempts were made to snare the separated portion, and the balloon was noted to migrate to the distal portion of the lad, possibly worsening the already poor flow in the vessel, so four xience sierra stents were implanted, one implanted to pin the separated balloon catheter segment to the arterial wall and the other three to open the flow in the vessel.Post procedure, the patient condition was improved.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
• MDR Report Key: 10341673
• MDR Text Key: 201451474
• Report Number: 2024168-2020-06308
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 1012449-15
• Device Lot Number: 90822G4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention