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

Catalog Number	1012405-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Excessive force; contrast dilution incorrect.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 and a review of the complaint history identified no other similar incidents from this lot.The trek coronary dilatation catheters (cdc) instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.Additionally, dilute contrast with normal saline 1:1.More concentrated contrast can lead to slower deflation times.The investigation was unable to determine a conclusive cause for the reported deflation issue.The reported separation and difficulty removing the device 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 during a procedure of a mildly tortuous, moderately calcified, mid left anterior descending artery (lad), the 2.5 x 12 mm trek balloon dilatation catheter (bdc) was advanced and used in the procedure without issue.Negative pressure was pulled two times for balloon deflation as a thicker contrast solution ratio was used.While attempting to remove the bdc from the anatomy, unspecified resistance was met.The device was pulled forcefully and the distal shaft separated, but remained in the guide catheter.The guide catheter, guide wire and device were removed as a system from the anatomy.The procedure was completed after additional pre-dilatation and stenting of the vessel were performed.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: 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: 7268798
• Report Number: 2024168-2018-01079
• Device Sequence Number: 19174397
• Product Code: LOX
• UDI-Device Identifier: 08717648153976
• UDI-Public: 08717648153976
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: 08/31/2020
• Device Catalogue Number: 1012405-12
• Device Lot Number: 70901G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1