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

Catalog Number 1012455-12

Device Problems Deflation Problem (1149); Material Separation (1562)

Patient Problems Intimal Dissection (1333); Cardiac Arrest (1762); Perforation (2001); Foreign Body In Patient (2687)

Event Date 07/10/2018

Event Type  Death  

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 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 percutaneous coronary intervention of a proximal left anterior descending (lad) artery to the left main (lm), a 5.0 x 12mm nc trek balloon dilatation catheter was used to post-dilate a deployed stent.After the first dilatation with the nc trek, a dissection of the lm was noticed.The balloon was re-dilated while a covered stent was prepared.During this time, while the balloon was inflated three times at 18, 16, and 8 atmospheres, cardiopulmonary resuscitation (cpr) was performed on the patient, and was then stopped to remove the balloon.Several seconds were held negative to deflate the balloon.The balloon would not deflate.The distal shaft separated into two pieces, and one piece remained in the anatomy.The catheter was simply removed leaving the balloon inflated and the distal shaft in the proximal lad.Numerous attempts were made to deflate the balloon using guidewires but it remained inflated.The patient was then transferred to another hospital for emergency bypass surgery where the distal shaft was successfully removed but it remains unknown if the balloon was retrieved.The patient is currently recovering in the intensive care unit (icu).No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: death checked and hospitalization and disability/permanent damage unchecked.Correction: type of event changed from serious injury to death.(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

Subsequent to the initially filed mdr report, it was confirmed the nc trek was inflated twice successfully at 18 and 16 atmospheres to post dilate the stent.A picture was taken at this point and a perforation was noted in the lad and not a dissection.The balloon was advanced and inflated a 3rd time to 8 atmospheres to stop the bleeding.At this time cpr was performed for approximately 2 minutes.Deflation of the nc trek was attempted for several seconds, but it would not deflate.The nc trek was then able to be removed without using force.Additionally, it was confirmed that the patient died on (b)(6) 2018.It is unknown if an autopsy was performed.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual inspection was performed and the reported shaft and balloon separations were confirmed.The reported deflation issue was unable to be confirmed due to the distal separated portion of the device not being returned.The reported patient effects of death and perforation are listed in the instructions for use nc trek rx coronary dilatation catheter as known patient effects of coronary stenting procedures.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 reported from this lot.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that the balloon catheter was inflated in the anatomy while cardiopulmonary resuscitation (cpr) was performed which likely compromised and/or damaged the inner/outer member materials.This damage in turn likely constricted the contrast from exiting the balloon during the last deflation resulting in the reported deflation issue.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Additionally, a cine was received and reviewed by an abbott vascular clinical specialist who concluded the following: the media provided does confirm that the reported device failed to deflate and remained inflated within the left anterior descending (lad) coronary artery.The rapid and repeated compression forces of active and effective cpr may have damaged the shaft such that it separated, similar to when a piece of metal is bent or flexed back and forth at a specific point.At this time a specific root cause cannot be determined although it is reasonable to infer that the active and effective cpr performed likely contributed to the device failure.

• 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: 7735939
• MDR Text Key: 115582933
• Report Number: 2024168-2018-05896
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1012455-12
• Device Lot Number: 80424G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2018
• 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): Death; Hospitalization; Required Intervention; Disability