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

Catalog Number 1012449-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: guide wire: runthrough, sion blue, guide cath: al1.0 , other: guideliner.The device was not returned for evaluation.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.Based on the information reviewed, there is no indication of a product quality issue.The investigation was unable to determine a conclusive cause for the reported complaints.

Event Description

The procedure was to treat a 99% stenosed, eccentric de novo lesion in the mid left anterior descending (lad) coronary artery.Due to heavy tortuosity and heavy calcification, a non-abbott child catheter was used the deliver the devices.During advancement of the 3.00 x15 mm nc trek balloon dilatation catheter (bdc) along the non-abbott child catheter, heavy resistance between the two was felt.Resistance was also felt while attempting to remove the bdc from the child catheter.Therefore; both the bdc and the child catheter were removed together and replaced.A new 3.00 x15 mm nc trek bdc was advanced to the lesion along a new non-abbott child catheter without issue.The procedure was completed successfully.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.

• 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
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5890801
• MDR Text Key: 52641203
• Report Number: 2024168-2016-05566
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: (01)08717648151873(17)180630(10)50721G1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1012449-15
• Device Lot Number: 50721G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 92