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

Catalog Number 1013067-15

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, heavily tortuous left anterior descending (lad) coronary artery.A 2.5x15mm traveler balloon dilatation catheter (bdc) was used in the lad successfully, and the bdc was retracted.The physician decided to use the bdc again, but the device faced resistance with the anatomy during advancement.Force was applied, the shaft kinked, and the proximal shaft separated outside the anatomy.An unspecified bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation and kink/bent were confirmed; however, the reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to advance appears to be related to operational context; however, the reported kink and separation appear to be related to user error.The account reported that the bdc was attempted to be re-inserted; however, resistance with the heavily calcified and heavily tortuous anatomy was experienced resulting in the reported failure to advance.The physician applied forced against the resistance and the bdc kinked and separated outside the anatomy.It should be noted the coronary dilatation catheters (cdc), traveler rx, global, instruction for use 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 applied forced against the reported resistance resulted in the shaft kinking and ultimately separating.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• Brand Name: TRAVELER RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11914101
• MDR Text Key: 253587759
• Report Number: 2024168-2021-04531
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 1013067-15
• Device Lot Number: 01125G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1