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

Catalog Number	1012445-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
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.Concomitant products: guide wire: asahi sion; guide catheter: heartrail2 6f al1.(b)(4).The device was not returned for evaluation.It should be noted that the nc trek rx, instructions for use, specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an eccentric de novo lesion in the mildly tortuous, moderately calcified, 90% stenosed posterior coronary artery.A 2.0 x 15 mm nc trek rx balloon dilatation catheter (bdc) was inserted into the anatomy, air aspiration was performed, and there was no issue or leak observed.The bdc was advanced toward the lesion with resistance, but crossed the lesion.On the first inflation to 5 atmospheres, the balloon ruptured.The bdc was removed from the anatomy with no resistance felt.A new 2.0 x 15 mm non-abbott bdc was used to complete the pre-dilatation and the procedure was completed with the successful deployment of a 2.5 x 20 mm non-abbott stent implant.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.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: 7324560
• Report Number: 2024168-2018-01660
• Device Sequence Number: 16545528
• Product Code: LOX
• UDI-Device Identifier: 08717648151651
• UDI-Public: 08717648151651
• 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,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: 02/28/2018
• Device Catalogue Number: 1012445-15
• Device Lot Number: 5032762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1