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

Model Number	1012454-12
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the ostial right coronary artery with heavy calcification and mild tortuosity.The lesion was prepared with rotablation and a 4.0x12 mm xience stent was successfully implanted.After post-dilation of the stent with the nc trek balloon dilatation catheter (bdc) for 2 inflations at 16 atmospheres, the stent was confirmed to be apposed to the vessel wall with intravascular ultrasound (ivus).There was resistance during removal; however, the balloon was noted to be fully deflated.The markers of the balloon did not move while withdrawing the catheter so the device was stretching.The nc trek balloon was trapped with a 2.5x12 mm trek bdc and removed along with the guide catheter.The stent was then post-dilated with a non-abbott nc balloon.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The reported stretching was confirmed.The reported entrapment of the device/resistance could not be replicated in a testing environment as it was based on operational circumstances.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.The investigation was unable to determine a conclusive cause for the reported entrapment of device/resistance; however, the reported stretched shaft and unexpected medical intervention appear to be related to circumstances of the procedure.Possible factors that can contribute to entrapment of device/resistance post-inflation include, but are not limited to, loose balloon folds, challenging anatomy, guiding catheter lumen obstructions, kinks, bends or, procedural technique.In this case, it is possible that the bdc interacted with the patient anatomy and/or accessory device resulting in the reported entrapment of device/resistance; however, a conclusive cause cannot be determined.Upon further manipulation of the device, in an attempt to remove it from the anatomy, the shaft became stretched.Additionally, the nc trek balloon was trapped with the trek bdc and removed along with the guide catheter.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The additional trek bdc is filed under a separate medwatch number.
Event or Problem Description
Subsequent to the initially filed report, the following clarification was received: it was reported that the procedure was to treat the ostial right coronary artery with heavy calcification and mild tortuosity.The lesion was prepared with rotablation and a 4.0x12 mm xience stent was successfully implanted.After post-dilation of the stent with the nc trek balloon dilatation catheter (bdc) for 2 inflations at 16 atmospheres, the stent was confirmed to be apposed to the vessel wall with intravascular ultrasound (ivus).There was resistance during removal; however, the balloon was noted to be fully deflated.The markers of the balloon did not move while withdrawing the catheter so the device was stretching.The nc trek balloon was trapped with a 3.0x12 mm trek bdc and removed along with the guide catheter.The stent was then post-dilated with a non-abbott nc balloon.There were no adverse patient sequela.The 3.0x12 mm trek balloon became kinked during use and returned device analysis identified a stretched inner member.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: 15855282
• Report Number: 2024168-2022-11887
• Device Sequence Number: 5216568
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: 08717648152108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 20629G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 02/05/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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: XIENCE 4.0X12MM DES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown