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

Catalog Number 1012272-15

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Respiratory Failure (2484); Foreign Body In Patient (2687)

Event Date 05/05/2017

Event Type  Death  

Manufacturer Narrative

(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 relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the 90% stenosed, heavily calcified left anterior descending (lad) artery. The 2. 5 x 15 trek rx balloon catheter was used for pre-dilatation of the lesion in the right coronary artery and then in the lad; however, the balloon ruptured on the second use, second inflation, at 18 atmospheres. Resistance was felt during advancement of the balloon catheter to the lesion. During removal, without resistance felt, it was found that the balloon had separated from the shaft of the catheter and the separated portion remained in the lad. Attempts to snare the separated segment failed. Medication was provided. The patient experienced a drop in blood pressure and a perforation was observed and the patient was hemorrhaging badly. It is unknown what caused the perforation; however, after aspiration was performed coils were placed for treatment. Chest compressions were performed. A tracheal jack was placed and ventilator assisted breathing treatment performed. Repeated injections of adrenaline, atropine, an intravenous drip and other rescue drugs were administered, after which the patient was transferred to the intensive care unit; however, post-procedure on the same day of treatment the patient died. No autopsy was performed. No additional information was provided.

Manufacturer Narrative

(b)(4). Correction: it was initially reported that the device would be returned for analysis. Subsequent information revealed that the device is not available for evaluation as it is being retained by the hospital. The device was not returned for analysis. The investigation determined the reported physical resistance appears to be related to circumstances of the procedure as the device likely interacted with the anatomy during advancement; however, a conclusive cause for the reported rupture and separation could not be determined. It should be noted that the, trek rx global instructions for use (ifu), states: balloon pressure should not exceed the rated burst pressure (rbp). In this case, it is possible the ifu deviation contributed to the reported event. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The reported patient effects of perforation, hypotension and death, as listed in the ifu, are known adverse events associated with the use of the device. The reported patient effects of hypotension, perforation, cardiac arrest, respiratory failure and foreign body in patient appear to be related to circumstances of the procedure. However, a conclusive cause for the reported patient effect of death, 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 of the device.

Manufacturer Narrative

(b)(4). Describe event or problem - correction.

Event Description

Subsequent to the previously filed medwatch, new information received noted that it was the tip of the catheter that separated, not the balloon itself. No additional information was provided.

• Brand Name: 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: 6609720
• MDR Text Key: 76586941
• Report Number: 2024168-2017-04748
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012272-15
• Device Lot Number: 61001G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/02/2017 Patient Sequence Number: 1