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

Model Number 1012455-12

Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems Non specific EKG/ECG Changes (1817); Ischemia (1942)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

(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 performed was to treat a left coronary (lm) artery.A 5.0x12mm nc trek balloon dilatation catheter was inflated twice at 15 to 16 atmospheres.It was noted that the balloon partially deflated only at the distal and proximal ends; the center still remained inflated.During removal of the balloon, which was still partially inflated, and non-abbott guide wire, force was applied and it was noted the patient's electrocardiogram (ecg) was altered and identified myocardial ischemia.However; the patient did not receive any treatment and the altered ecg and myocardial ischemia resolved after balloon removal.Also, the balloon appeared to look deformed once removed.There was no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

Device code 2017 / contrast incorrect.Visual, dimensional and functional inspections were performed on the returned device.The reported failure to fold (deformed balloon) was confirmed; however, the reported deflation issue could not be confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported failure to fold (deformed balloon) and difficulty removing the device appears to be related to operational context.In this case, a conclusive cause for the reported deflation issue could not be determined since the complaint could not be confirmed during return analysis.Return analysis noted wrinkles sporadically through out the entire length of the balloon.In this case, since the device had a larger balloon profile and the balloon was attempted to be removed partially inflated, it ultimately became wrinkled/bunched and gave the impression of a deformed balloon.Furthermore, the reported difficulty removing the device was due to the balloon being removed partially inflated as deflation could not be completed.Force was applied and it was noted the patient's electrocardiogram (ecg) was altered and identified myocardial ischemia.A conclusive cause for the reported ekg/ecg changes and ischemia and the relationship to the device, if any, cannot be determined.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.It should be noted that coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, the device was removed against resistance given the clinical circumstances.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H10: device code 2017 - contrast incorrect was added.

• 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: 11043120
• MDR Text Key: 223175999
• Report Number: 2024168-2020-10749
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 00610G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SION GUIDE WIRE
• Patient Outcome(s): Other