MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Model Number	1012272-30
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during a left main/left anterior descending coronary artery intervention, during use of a trek balloon dilatation catheter, the balloon failed to deflate, and the shaft separated.The separated portion was successfully snared out of the anatomy.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was provided: there was resistance during withdrawal of the balloon dilatation catheter and force was applied.No additional information was provided.
Additional Manufacturer Narrative
H6: device code 2017- excessive force.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 similar incidents and/or complaints from this lot.It should be noted that the coronary dilatation catheters (cdc), trek rx global, 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.In this case, it is likely that the force contributed to the reported separation; however, force was required to remove the device given the clinical situation.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device, removal of foreign body and additional treatment 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.E1: physicians name d10, h3: device not available for evaluation.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation and deflation problem were unable to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, it was noted that the inner and outer member were stretched and bunched, the guide wire exit notch was stretched, and the outer member was torn.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that manipulation of the device and/or an insufficient amount of time was not allowed before an attempt to remove the device resulting in the noted stretched and bunched inner and outer member; thus, reducing the inflation/deflation lumen resulting in the reported deflation problem and the reported difficult to remove.Manipulation of the device using force resulted in the multiple device damages (torn guide wire exit notch, torn outer member).There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3: device available for evaluation h6: method code 4114 - removed.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9639954
• Report Number: 2024168-2020-00953
• Device Sequence Number: 16870910
• Product Code: LOX
• UDI-Device Identifier: 08717648138324
• UDI-Public: 08717648138324
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012272-30
• Device Catalogue Number: 1012272-30
• Device Lot Number: 90822G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/05/2020; 07/22/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/26/2020; 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention