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

Model Number 1012453-15

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/10/2021

Event Type  malfunction  

Manufacturer Narrative

Attachment: (b)(4).The device location was not provided.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

User facility medwatch report (b)(4) received that states "patient admitted with cp x few weeks and found to have st-elevated myocardial infarction stem!.The patient was taken to the catheterization lab for angiography and potential percutaneous intervention.During the procedure, coronary balloon, from nc trek coronary dilatation catheter, could not be removed from guide catheter during angioplasty/stent procedure.The body of the balloon telescoped inside itself and made a hard ridge that got stuck on guideliner making it impossible to be removed from guide catheter.As a result, the entire system had to be removed.Additional notes.Drug-eluting stent placed and post-dilated with a 4.0 x 15 mm nc trek balloon at high pressure.Health care providers were unable to pull the deflated balloon completely back into the guide, so the entire system was removed as one.The balloon then stuck as it was entering the radial sheath.The balloon was advanced over the wire a bit, inflated to very low pressure, and then successfully withdrawn as it was deflated.Inspection of the balloon revealed that the more distal edge that had failed to assume a lower profile." additional information was received from the account: it was reported that the procedure was to treat a 100% stenosed vessel in the proximal left circumflex artery.A 6fr guiding catheter was used.The nc trek balloon dilatation catheter (bdc) was not air aspirated outside of the anatomy prior to use.During post dilatation, the nc trek was inflated 3 times with a pressure of 20 atmospheres (atm) each inflation.Negative pressure was held for 15 seconds and it was noted that the balloon deflated so that the distal end was sucked into the center [fold issue].As a result the bdc could not be removed through the guiding catheter.The nc trek bdc was removed as a single unit with the guide catheter but met resistance at the sheath.The balloon was therefore slightly re-inflated.Upon deflation, the balloon was able to be successfully removed without intervention.There were no adverse patient effects and there was no significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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.The investigation was unable to determine a conclusive cause for the reported failure to fold (unusual appearance) balloon; however, the reported difficulties removing the device appears 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.E3: occupation.

Event Description

N/a.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12366164
• MDR Text Key: 268094257
• Report Number: 2024168-2021-07522
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 10213G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F GUIDELINER; 6F GUIDELINER
• Patient Age: 75 YR
• Patient Weight: 96