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

Catalog Number 1013153-15

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Occlusion (1984)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.(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 the procedure was to treat a heavily calcified, 75% stenosis in the left anterior descending coronary artery.After a rotablator was used in the anatomy, the 3.0x15 mm nc traveler rx balloon dilatation catheter (bdc) was advanced to the target lesion.The balloon was inflated to 18 atmospheres (atm) and then to 26 atm and the balloon ruptured.Resistance was felt with the guide catheter during removal of the nc traveler bdc; it felt like something had stretched and it sounded like something detached.Once the bdc was outside the patient, it was confirmed a circumferential detachment occurred; approximately 3/4 of the balloon material had detached inside the patient anatomy.It was noted that the inner member separated proximal to the proximal marker.Both markers are present on the inner member but both are stretched.After the balloon ruptured, an acute coronary occlusion occurred.The occluded vessel was dilated with a 2.0mm bdc and timi 3 flow was regained.The separated segment was difficult to locate with angiography, markers were not visible.Optical coherence tomography (oct) was used to locate the separated segment; the proximal half of the separated balloon was inside the guide catheter.An unspecified guide wire and unspecified balloon dilatation catheter were used to trap the separated balloon inside the guide catheter.The separated balloon was removed together with the guide catheter and other devices.A rotablator and an unspecified non-abbott bdc were used to dilate the lesion but the vessel could not be dilated and the balloon also ruptured.As the lesion could not be dilated, the patient then underwent cabg.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection and fluoroscopy imaging were performed on the returned device.The balloon rupture, stretching and separation were confirmed.The difficulty to remove could not be replicated in a testing environment due to the condition of the returned device.The marker visibility issue 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 incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.It was reported that the nc traveler rx balloon was inflated above rated burst pressure (rbp) and subsequently ruptured.It should be noted that the coronary dilatation catheters, nc traveler, rx, instructions for use (ifu) states: balloon pressure should not exceed the rbp.The investigation determined the reported balloon rupture appears to be related to user error.The reported difficulty to remove, stretching and separation appears to be related to circumstances of the procedure; however a conclusive cause for the reported marker visibility issue cannot be determined.The reported patient effect of occlusion, as listed in the nc traveler ifu, is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the treatments appear to be related to the operational context of the procedure.

• Brand Name: NC TRAVELER 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: 5752592
• MDR Text Key: 48291348
• Report Number: 2024168-2016-04155
• Device Sequence Number: 1
• Product Code: LOX
• 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,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1013153-15
• Device Lot Number: 50525G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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 Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR