MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number 1012451-20

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Thrombosis (2100)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 chronic totally occluded and calcified lesion in the right coronary artery (rca).Mild resistance was noted while removing a stylet from the 3.5x20mm nc trek rx balloon dilatation catheter (bdc).The bdc was advanced and inflated once to 18 atmospheres without reported issue; however, the balloon could not deflate after pulling negative multiple times for a total of 8 minutes.It was also noted that unspecified indeflators were exchanged while trying to deflate the bdc balloon.The balloon remained inflated in the rca for 9 minutes before it was fully deflated and removed without issue from the patient; however, thrombus was noted, and an unspecified semi-compliant bdc was used to remove the thrombus and complete the procedure.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual, dimensional and functional analysis were performed on the returned device.The reported deflation issue was not confirmed.The reported difficulty removing the mandrel/stylet could not be replicated in a testing environment because the component was not returned.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the mandrel/stylet and deflation issue; however, the reported additional treatment appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of thrombosis and the relationship to the product, 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.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8675389
• MDR Text Key: 147215838
• Report Number: 2024168-2019-04485
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 1012451-20
• Device Lot Number: 81227G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR