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

Catalog Number	1012453-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: medical device problem code 2017 - incorrect prep.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.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters, nc trek rx, 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 violation of the ifu caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported difficulty removing the device, separations, unexpected medical intervention and delay to treatment/therapy appear to be related to circumstances of the procedure.Possible factors that may contribute to failure to deflate include, but are not limited to, manufacturing, deflation technique, contrast concentration, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigation's have been established for potential causes.Additionally, it is likely that the balloon being removed inflated contributed to the reported difficulty removing the device and subsequently upon manipulation of the device, as difficulty was encountered, the balloon and shaft ultimately separated.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in distal left main artery.The 4.0x12mm nc trek balloon was not soaked in saline prior to use (per instructions for use).The nc trek balloon dilatation catheter (bdc) was advanced to the lesion without resistance.The balloon was inflated one time, but when attempting to deflate the balloon, it failed to deflate.During the attempt to remove the bdc, the shaft separated.The proximal end of the bdc was easily removed; however, the distal shaft and balloon had to be retrieved with a lasso.The procedure was delayed 30 minutes due to the issues with the bdc.A new access site was used to complete the procedure.There was no adverse patient sequela.No additional information was provided.

• 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: 18057891
• Report Number: 2024168-2023-12180
• Device Sequence Number: 5954709
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: 08717648152061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 1012453-12
• Device Lot Number: 30216G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown