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

Catalog Number 1012453-12

Device Problems Detachment Of Device Component (1104); Kinked (1339); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 a procedure to treat an unspecified coronary artery, a 4.0x12 mm nc trek balloon dilatation catheter (bdc) was advanced without resistance in the patient anatomy for post dilatation.After the bdc was successfully used for post dilatation, a kink was noted on the proximal shaft.When attempting to straighten the kink, the proximal shaft separated near the hub.The separated portion of the sds was simply withdrawn from the patient anatomy without issue.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported shaft kink and the reported shaft detachment were 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 investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error as it is likely that inadvertent mishandling during the procedure resulted in the reported shaft kink.It should be noted that coronary dilatation catheters (cdc), nc trek rx, global, instructions for use, states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6879714
• MDR Text Key: 87766464
• Report Number: 2024168-2017-07612
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1012453-12
• Device Lot Number: 70206G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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