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

Catalog Number 1012455-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem Intimal Dissection (1333)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is unknown if the device is returning for analysis.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in an unknown artery.A 5.0x12 nc trek balloon was being used to post-dilate a 4.0 non-abbott stent.After use, the balloon only partially deflated but was able to be pulled out of the left main after using heavy force.An attempt was then made to puncture the balloon with two non-abbott guide wires but this was unsuccessful.The device was fully inflated in the brachial artery where the balloon was punctured percutaneously with a needle at the traditional location of the arteria brachialis function.It was then possible to retract 80% of the deflated balloon into the sheath with only the distal part that could not be retracted into the sheath.The sheath was pulled together with the balloon and the radial artery was successfully closed with the non-abbott closure device.There was a need for a second sheath in the femoral artery and a second stent in the left main because of dissection and stent deformity due to forceful withdrawal of the balloon.The radial artery was successfully closed.There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.

Event Description

Subsequent to the previously filed medwatch report, the procedure was to treat a calcified ostial left main lesion that was 99% stenosed.No additional information was provided.

Event Description

Subsequent to the previously filed medwatch report, it was reported that the balloon was inflated once to 20 atmospheres for 20 seconds.No additional information was provided.

Manufacturer Narrative

Device codes: 2017 labeled.(b)(4).Device code 2017: use above rated burst pressure.Evaluation summary: a visual inspection was performed on the returned device.The reported deflation issue, difficult to remove and device damaged by another device were unable to be confirmed due to the returned condition of the device.The reported patient effect of dissection is listed in the instructions for use (ifu) nc trek rx coronary dilatation catheter, as a known patient effect of coronary stenting procedures.A cine was received and reviewed by an abbott vascular clinical specialist.The media provided for review does show the partially deflated 5.0 mm x 12 mm nc trek balloon at the distal end of the introducer sheath located in the radial artery.Additional imaging shows what appears to be the same balloon during its single inflation (20 atmospheres (atm) for 20 seconds) within a previously deployed stent (non-abbott) located at the ostium of the left main coronary artery.Based on the images, the report provided and the device inspection, there does not appear to be a specific root cause for this failure that can be attributed to either the device, the anatomy or the user.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It was reported that the balloon was inflated once to 20 atmospheres for 20 seconds during inflation.It should be noted that the instructions for use (ifu), cdc, nc trek rx, global, states: balloon pressure should not exceed the rated burst pressure (rbp).The pressurization of the balloon above rbp does not appear to have contributed to the reported difficulties.The investigation was unable to determine a conclusive cause for the reported deflation issue.Although a conclusive cause for the reported deflation issue could not be identified, the reported difficulty to remove, device damaged by another device and noted device damages appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: NC TREK 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: 7914949
• MDR Text Key: 121910894
• Report Number: 2024168-2018-07456
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1012455-12
• Device Lot Number: 80417G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: 4.0 SYNERGY; STENT: 4.0 SYNERGY
• Patient Outcome(s): Required Intervention