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

Catalog Number 1012453-12

Device Problems Deflation Problem (1149); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.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 right forearm arterial venous dialysis fistula.A 4.0x12mm nc trek balloon dilatation catheter (bdc) prepared per the instructions for use.The contrast mix was 30:70.The balloon was inflated one time to 16 atmospheres for 30 seconds; however, the balloon would not deflate even after a negative was pulled three times.Since the balloon catheter was used in the forearm fistula, which is close to the skin, the physician was able to use ultrasound to find the inflated balloon and used a needle to pop the balloon.The balloon deflated and was removed without any issues.The procedure was successfully completed with an unspecified device.There was no adverse patient sequela and no clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions 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.Additionally, it was reported that the device was used to treat a right forearm arterial venous dialysis fistula.It should be noted that the ifu states: the nc trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.In this case, it is unknown if the ifu deviation caused or contributed to the reported complaint.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 additional treatment appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this 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: 8936878
• MDR Text Key: 156014259
• Report Number: 2024168-2019-11211
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: 08717648152061
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 1012453-12
• Device Lot Number: 90406G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR