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

Catalog Number	1012446-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.It was reported that the device was prepared inside of the patient anatomy.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: caution: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during preparation for treatment of a heavily calcified, 90% stenosed, 15mm-long lesion in the moderately tortuous 2.3mm-diameter right posterior descending coronary artery, a 2.25x12mm nc trek rx balloon dilatation catheter (bdc) was unpackaged without difficulty and the device soaked in saline.Air aspiration of the device was performed while inside of patient anatomy.The nc trek rx bdc was advanced to the lesion without resistance.During the 1st inflation the balloon ruptured at 15 atmospheres.The nc trek rx bdc was withdrawn without difficulty.Dilatation was completed using a 2.5x15 non-abbott bdc, followed by deployment of a non-abbot stent, resulting post-procedure stenosis of 15%.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6156532
• Report Number: 2024168-2016-08717
• Device Sequence Number: 19012000
• Product Code: LOX
• UDI-Device Identifier: 08717648151699
• UDI-Public: (01)08717648151699(17)180831(10)50919G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1012446-12
• Device Lot Number: 50919G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2016
• Initial Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1