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

Catalog Number 1012272-15

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problems Angina (1710); Ischemia (1942)

Event Date 11/22/2018

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The nc trek referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a de novo lesion in a mildly calcified distal right coronary artery that was 90% stenosed.Pre-dilatation was performed with a 2.5 x 15 mm trek balloon catheter.However, the device met resistance during removal and the patient felt pain and had timi ii flow.Therefore, an attempt was made to advance a 2.5 x 15 mm nc trek balloon catheter for pre-dilatation; however, the device met resistance with a guide wire during advancement.When the device was inspected, it was noted that a part of the balloon had separated inside the anatomy.Therefore, an aspiration catheter was used to remove the balloon.The procedure was then aborted and the patient was scheduled for another procedure with rotablation.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1562 not labeled.Internal file number - (b)(4).Correction: device code 1104 added.Evaluation summary: a visual inspection was performed on the returned device.The reported balloon separation was confirmed.The reported difficulty to remove from the anatomy was unable to be replicated in a testing environment as it was based on operational circumstances.A cine was received and reviewed by an abbott vascular clinical specialist.Images were unable to be transferred via dicom reader; therefore, were reviewed via windows media player which does not allow for frame by frame assessment.The balloon tear reported on the 2.5 x 15 trek and pinhole reported on the 2.5 x 15 nc trek were not visible on the cines provided.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 determined the reported difficulties to remove and balloon separation appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of angina is listed in the instructions for coronary dilatation catheter trek rx and mini trek rx global as a known patient effect of the coronary procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, additional information was received.The 2.5 x 15 mm trek device met resistance with the anatomy during removal and the balloon separated from the device.It was retrieved with an aspiration catheter.The nc trek balloon catheter did not meet resistance with the guide wire during advancement; however, a pinhole in the balloon was noted and the balloon was not able to completely inflate.It ruptured during its first inflation at nominal pressure.

• 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
• MDR Report Key: 8160751
• MDR Text Key: 130226281
• Report Number: 2024168-2018-09642
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 1012272-15
• Device Lot Number: 80929G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention