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

Catalog Number 1012452-12

Device Problem Break (1069)

Patient Problems Air Embolism (1697); Bradycardia (1751)

Event Date 02/07/2017

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 was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the left anterior descending artery.During pre-dilatation of the lesion, when the 3.75 x 12 mm nc trek balloon was inflated, a gaseous emboli leak occurred due to a spontaneous shaft break.The leak occurred at low (nominal) pressure causing bradycardia (vagal) which was treated with adrenaline and atropine.The patient was kept in the hospital for an overnight stay for observation.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported shaft separation was confirmed.The reported leak could not be replicated/tested in a testing environment due to the condition of the returned device.The reported patient effects of embolism and bradycardia, which is considered synonymous to arrhythmia, are listed in the coronary dilatation catheters (cdc), nc trek rx, instruction for use are known patient effects.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 of the reported lot identified no other similar incidents from this lot.The investigation determined the reported complaints and patient effects appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

Event Description

Subsequent to the previously filed medwatch report, new information was received as follows: no device issues were noted during preparation of the device prior to use.There was no resistance felt during removal of the protective sheath or during advancement of the catheter to the lesion.The shaft separation observed resulted in air coming from the catheter.There was no issue during removal of the separated shaft from the patient.Another balloon catheter was used to complete the procedure.The final outcome for the patient was good.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: 6411829
• MDR Text Key: 70174368
• Report Number: 2024168-2017-02218
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1012452-12
• Device Lot Number: 61102G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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): Required Intervention