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

Catalog Number 1012455-08

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a lesion in the ostial superior mesenteric artery (sma) of a previously implanted unspecified stent with moderate tortuosity and no calcification, a balance middleweight (bmw) hydro guide wire was advanced.A 5.0x8 mm nc trek rx dilatation catheter was advanced without resistance and pre-dilatation was performed.Reportedly, the balloon was inflated up to 20 atmospheres (atm) and upon removal the dilatation catheter became stuck on the bmw hydro guide wire and could not be removed.The dilatation catheter and bmw hydro guide wire were removed from the patient anatomy as a single unit.The dilatation catheter was noted to have poor re-fold.The sma was re-wired with a new bmw hydro guide wire and unspecified stent was implanted.A new 5.0x8 mm nc trek rx dilatation catheter was advanced without resistance and post-dilatation was performed.Reportedly, the balloon was inflated up to 24 atm and upon removal the dilatation catheter became stuck on the bmw hydro guide wire and could not be removed.The dilatation catheter and bmw hydro guide wire were removed from the patient anatomy as a single unit.The dilatation catheter was noted to have poor balloon re-fold.Reportedly, the dilatation catheters were prepped per the instructions for use without any issues noted.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4) - use in incorrect anatomy, inflation above rated burst pressure.The two bmw hydro guide wires and the other 5.0x8 mm nc trek rx dilatation catheter referenced are filed under separate medwatch mfr numbers.Evaluation summary: the device was returned for evaluation.The reported resistance with the guide wire and poor refold were confirmed.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.It should be noted that the nc trek, global instructions for use (ifu) states: the nc trek rx coronary dilatation catheters is indicated for - balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, and balloon dilatation of a stent after implantation.It was also reported that the nc trek balloon was inflated to above rbp.It should be noted that the nc trek rx ifu warns: balloon pressure should not exceed the rated burst pressure (rbp).Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 4566043
• MDR Text Key: 15124610
• Report Number: 2024168-2015-01153
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• 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: 02/06/2015

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: 09/30/2015
• Device Catalogue Number: 1012455-08
• Device Lot Number: 210166N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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
• Treatment: BALANCE MIDDLE WEIGHT HYDRO GUIDE WIRE
• Patient Age: 71 YR
• Patient Weight: 56