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

Catalog Number 1013159-08

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

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 received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The nc 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 to treat a mildly calcified distal left circumflex artery.A 5.0 x 8 mm nc traveler balloon dilatation catheter (bdc) was used and was advanced to the lesion with an unspecified guideliner.The bdc met initial resistance with the anatomy, and the device was inflated once below the rated burst pressure.However, the device was not able to be removed from the guideliner after deflation as the balloon was winged.Therefore, the devices were removed from the anatomy as a single unit.The device was then replaced with a non-abbott 4.4 mm bdc with the same guideliner to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and functional inspections were performed on the returned device.The reported folded (winged) balloon and difficulty removing the device from the guiding catheter were confirmed.The reported physical resistance 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.It should be noted that the coronary dilatation catheters (cdc), nc traveler rx, instruction for use states: caution: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported folded (winged) balloon; however, the reported difficulty removing the bdc from the guiding catheter and physical resistance appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TRAVELER CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7434538
• MDR Text Key: 105760127
• Report Number: 2024168-2018-02820
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1013159-08
• Device Lot Number: 51106G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: GUIDELINER