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

Catalog Number 1012273-12

Device Problem Material Rupture (1546)

Patient Problems Angina (1710); Ischemia (1942)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Correction: patient identifier. Correction: the date received by mfr. Date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017.

Manufacturer Narrative

Internal file number - (b)(4). The device was not returned for evaluation. A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided. The reported patient effect angina as listed in the coronary dilatation catheters trek rx instructions for use is a known patient effect. The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported patient effects appear 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).

Event Description

It was reported that the procedure was to treat an unspecified coronary artery. A 2. 75 x 12 mm trek balloon dilatation catheter (bdc) was used; however, the balloon ruptured. This resulted in insufficient blood flow to the artery and the patient experienced angina. Therefore, the bdc was withdrawn immediately. After the catheter was replaced with another unspecified device the patient improved. There was no adverse patient sequela reported. 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7195647
• MDR Text Key: 167718321
• Report Number: 2024168-2018-00408
• 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,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1012273-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial