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

Catalog Number 1012454-08

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported that the nc trek was prepared without issue then inflated below rated burst pressure twice for approximately ten seconds to post dilate the non-abbott stent in the non-tortuous, non-calcified left main coronary artery.The nc trek appeared to inflate and deflate appropriately.When the nc trek was retracted to the guide catheter, resistance was met with the guide catheter, but the nc trek was completely removed.There were no adverse patient effects and no clinically significant delay in the procedure.The nc trek remained in one piece, but the balloon appears mangled.After removal, the customer attempted to inflate the nc trek, but it would not inflate.No additional information was provided.

Manufacturer Narrative

(b)(4).Estimated age.Estimated weight.Evaluation summary: the device was received.The reported difficult to remove from the guiding catheter could not be confirmed due to the condition of the returned device.The reported unusual appearance of the balloon was confirmed.A review of the electronic lot history record revealed no nonconformances from this lot.A query of the complaint handling database found no similar incidents for difficult inflation or unusual appearance.Based the information reviewed, visual and functional analysis of the returned device, 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): 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: 4330543
• MDR Text Key: 5132426
• Report Number: 2024168-2014-08189
• 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: 11/21/2014

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: 11/30/2015
• Device Catalogue Number: 1012454-08
• Device Lot Number: 31007G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: RESOLUTE STENT
• Patient Age: 70 YR
• Patient Weight: 91