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

Model Number	1012453-15
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulty to advance and difficulty to remove could not be confirmed due to the condition the device was received from the account.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to advance and difficulty to remove from the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the proximal to mid left anterior descending (lad) artery.A hi-torque (ht) balance middleweight (bmw) universal ii guide wire was advanced successfully and pre-dilatation was performed using multiple non-abbott balloons.The mid lad was further treated using a 3.5x38mm xience sierra stent and was post dilatated with a 3.5x12mm nc trek balloon per standard procedure.The proximal lad was treated successfully using a 4.0x28mm xience sierra stent, however, post-dilatation per standard procedure was attempted but the 4.0x15mm nc trek could not be advanced possibly due to the guide wire.Another 4.0x15mm non-abbott non-compliant (nc) balloon and another 5.0x12mm nc trek balloon were used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified that there was a longitudinal tear in the inner member 4.9cm proximal to the proximal balloon seal for a length of 0.5mm.There was a longitudinal tear in the outer member 5cm proximal to the proximal balloon seal for a length of 0.5mm.The account was not aware of the tear.It was confirmed that the failure to cross was due to interaction with guide wire and there was resistance during removal with the guide wire but was removed independently.No additional information was provided.
Additional Manufacturer Narrative
Subsequent to filing the initial report, update to mfg narrative: visual analysis was performed on the returned device.The reported difficulty advancing and difficulty removing was unable to be confirmed due to the returned device condition.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 incidents from this lot.Based on the reported information and evaluation of the returned device, the reported difficulty advancing and difficulty removing appears to be related to procedural circumstances.The location of the tear/puncture noted in the guidewire lumen and exiting the outer member is consistent with a puncture from the guidewire.It is likely that while advancing the nc trek over the guidewire, the distal shaft of the nc trek was bent or angled such that the proximal end of the guidewire punctured through the shaft resulting in difficulty advancing and resistance during removal from the guidewire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: investigation conclusions code 4315 removed; 4307 added.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: 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: 17058776
• Report Number: 2024168-2023-05849
• Device Sequence Number: 15587579
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 21011G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X38MM XIENCE SIERRA STENT; 4.0X28MM XIENCE SIERRA STENT; INTRAVASCULAR ULTRASOUND (IVUS)
• Patient Sex: Unknown