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

Catalog Number 1012455-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion from the left main trunk (lmt) to the left anterior descending artery (lad).There was no tortuosity and no calcification.A xience xpedition stent was implanted and the 5.0 x 12 mm nc trek balloon catheter was advanced for post-dilatation.Air aspiration of the balloon catheter was performed inside the patient anatomy.The nc trek balloon was inflated to 12 atmospheres (atm) and then deflated.It was noted that the deflation took longer than usual, but the specific time was unknown.The balloon was pulled into the guiding catheter from the lesion before the balloon was fully deflated because the lesion was in the lmt.It was also noted that the balloon was wrinkled and that resistance was noted with the guiding catheter during removal.The procedure was then completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported deflation difficulty and wrinkled balloon was confirmed.The reported resistance with the guiding catheter could not be tested due to the condition of the returned device.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 incidents for deflation difficulty, resistance with the guiding catheter or wrinkled balloon reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Because it was reported that air aspiration was performed inside the patient, it should be noted that the preparation for use section of the nc trek coronary dilatation catheter instructions for use (ifu) states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body; otherwise, complications may occur.It is unknown if the ifu deviation contributed to the reported difficulties.

• 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: 4547428
• MDR Text Key: 5508658
• Report Number: 2024168-2015-01023
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 09/30/2017
• Device Catalogue Number: 1012455-12
• Device Lot Number: 41016G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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: STENT: XIENCE XPEDITION