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

Catalog Number 1012274-20

Device Problems Break (1069); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2013

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified right coronary artery (rca).During advancement of a 3.5 x 33 mm xience xpedition stent delivery system (sds), the stent got stuck in the proximal calcified rca.When removing the sds, when only partially into the guiding catheter, the stent implant could not be pulled further into the guiding catheter and also could not be moved forward.The devices were being removed as a single unit; however, at the proximal edge of the sheath, the guide came out, but the stent dislodged and remained in the radial artery.The stent could be seen at the skin surface at the wrist, so a cutdown was made and the stent was pulled out with hemostats.The patient was hemodynamically stable and there was no hematoma on the wrist.The patient returned to the lab on (b)(6) 2013 for a successful femoral percutaneous coronary intervention (pci) of the rca.No additional information was provided.Additional parts were received in the returned goods lab that were used during the procedure.These will be reported for: a 3.0 x 20 mm trek balloon catheter was separated at the proximal seal.A 2.5x 20 mm trek was separated at the guide wire exit notch.A 2.0 x 20 mm mini trek the outer member was wrinkled and torn at the proximal balloon seal.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The xience xpedition, trek and mini trek are being filed under separate manufacturing report numbers.Evaluation summary: the device was returned without any complaints of product quality deficiency to confirm.As observed on the return, there was damage to the catheter which was likely due to the use of the catheter to unsuccessfully retrieve the dislodged stent.A review of the lot history record revealed no non-conformances that would have contributed to the observed damage.Review of the similar incidents complaint history of the reported lot did not indicate a manufacturing issue.Based on the visual inspection of the returned device, there is no indication of a product quality deficiency.Based on the information reviewed and return analysis, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3601029
• MDR Text Key: 4161008
• Report Number: 2024168-2014-00542
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 1012274-20
• Device Lot Number: 30726G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2014
• Initial Date FDA Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 95