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

Catalog Number 1012455-08

Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.(b)(4).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 of the reported lot did not indicate a lot specific quality issue.It was reported that the nc trek bdc was over inflated to 22 atmospheres (atms) during the second inflation.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.Additionally, it was reported that the balloon was not soaked prior to use.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint; therefore, a letter will not be required for the account.The investigation was unable to determine a conclusive cause for the reported deflation issue and failure to fold (loosely folded) balloon; however, the reported difficulty removing the device from the guiding catheter 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.The other additional nc trek referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion in the non-tortuous, heavily calcified, 75% stenosed ostial coronary artery.A non-abbott 4x16mm stent was implanted, and a 5x8mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation once at 22 atmospheres.During removal, the bdc faced resistance with the non-abbott guiding catheter, so it was removed with all the devices.Upon removal, the guiding catheter was noted to be damaged and the balloon partially deflated and did not refold tightly.Two more non-abbott guiding catheters were used, and a portion of the implanted non-abbott stent was was crushed.A 5x8mm nc trek bdc was used for post-dilatation successfully.During removal, the bdc faced resistance with the non-abbott guiding catheter, so it was removed with all the devices.No damage was noted on this device.A 5x15mm and a 5.5x15mm non-abbott, non-compliant balloon 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.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9446311
• MDR Text Key: 177939046
• Report Number: 2024168-2019-14351
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 1012455-08
• Device Lot Number: 90719G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 78