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

Catalog Number 1012272-15

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant products: guide wire: runthrough. Guiding catheter: cordis 6fr jr 3. 5 sh. 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 the procedure was to treat a lesion in the mid left anterior descending artery with mild tortuosity and moderate calcification. A 2. 5x15 mm rx trek balloon dilatation catheter (bdc) was unable to advance through a 6 fr non-abbott guide catheter. The non-abbott guide wire was damaged and the trek bdc was stuck inside of the guide catheter. A new non-abbott guide wire and a new 2. 5x15 mm rx trek bdc were able to be advanced through the same non-abbott guide catheter. Angioplasty was successfully performed. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported difficulty to remove and difficulty to position issues could not be confirmed. The investigation was unable to determine a conclusive cause for the reported difficulties. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 5988764
• MDR Text Key: 56335449
• Report Number: 2024168-2016-06538
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 11/15/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1012272-15
• Device Lot Number: 60604G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial