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

Catalog Number 1012451-08

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Visual inspection was performed on the returned device. The reported separation was confirmed. The reported balloon rupture could not be confirmed due to the condition of the returned device. It was reported that the balloon ruptured at 22 atmopsheres, which is above the rated burst pressure. It should be noted that the nc trek rx coronary dilatation catheters instructions for use states: balloon pressure should not exceed the rated burst pressure. 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 identified no other similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported balloon separation 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 the device.

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 relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending artery. A 3. 5 x 8 mm nc trek balloon dilatation catheter was being used for post-dilatation; however, the balloon ruptured during first inflation at 22 atmospheres. The balloon ruptured in a way that it separated and half of the balloon is lost in the patient. The guiding catheter was flushed; however, the missing balloon piece was not there. The case was concluded and the patient was monitored overnight; however, has since been discharged home. There was no clinically significant delay in the procedure and no adverse patient effects. 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: 6669946
• MDR Text Key: 108174067
• Report Number: 2024168-2017-05391
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1012451-08
• Device Lot Number: 70313G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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: 06/27/2017 Patient Sequence Number: 1