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

Model Number 1012455-12

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)

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

Event Date 03/30/2022

Event Type  Injury  

Event Description

User facility medwatch states: [patient underwent successful balloon angioplasty as well as shockwave lithotripsy assisted angioplasty and expansion of his prior stenting up with a 5.0 non-compliant balloon at high pressures.The procedure was complicated by inability to deflate the 5.0 non-compliant balloon and inability to retract it into the guide out of the coronary artery.Surgery team was ultimately able to rupture the balloon with pooling of all equipment out through this sheath in the groin with some difficulty.On post-op imaging, this patient had no residual vascular complication from multiple attempts at puncturing the coronary balloon for deflation.The patient suffered no complications from this procedure.] additional information received confirms that the lesion location treated was the proximal right coronary artery that was 90% stenosed.The procedure involved a 5x12mm nc trek balloon.There was no resistance when advancing the device to the lesion.Contrast mix was 60/40.The nc trek was inflated 3 times inflated between 15-18 atmospheres.The device was repositioned between inflations.For deflation, at first 5-8 seconds were held negative but when the physician realized there was a deflation issue occurring then he held negative for 10-15 seconds about 2-3 times and the balloon would not deflate.Resistance with the sheath was met as the balloon was ultimately pulled through with all the equipment through the sheath against resistance.The device remained intact in one piece without any other issues noted.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is retained by hospital and not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attached medwatch report #: mw5108925.

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.It was reported that force had to be applied to remove the bdc as the balloon would not deflate.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, the ifu deviation did not contribute to the reported complaint, and force was required to remove the device given the clinical situation.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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
• 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: 14342717
• MDR Text Key: 291288600
• Report Number: 2024168-2022-05060
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 10429G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 41 KG