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

Model Number	1012455-12
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 99% stenosed lesion in the left main (lm) artery.A 5x12mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and inflated three times.The first inflation was to 10 atmospheres (atm), and the second and third inflations were to 16 atm.Negative was held for almost one minute however the balloon was very slow to deflate.The balloon would not retract into the guide liner.Resistance was felt during removal, and the shaft of the device separated into two pieces with approximately 20cm of the shaft inside the patient and the other part of the shaft hanging out of the guideliner.Additionally, the balloon separated into 2 pieces.A balloon was used to trap the separated portion of the shaft and the balloon in the gc and the bdc was pulled back into the radial sheath.The radial sheath was then removed.No additional information was provided.
Additional Manufacturer Narrative
Visual inspections were performed on the returned device.The reported deflation issue and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.It was noted that the outer member was separated distal to the guidewire exit notch and the inner member was separated distal to the guidewire exit notch, confirming the reported separation; however, the reported balloon separation was not confirmed.In this case, it is likely that the account perceived the balloon as separated since the other side of the bdc was reported as hanging out of the guideliner.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported deflation issue could not be determined; however, the reported difficulty removing the device, removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.The investigation determined the reported shaft separation and confirmed outer member separation distal to the guidewire exit notch and the inner member separation distal to the guidewire exit notch during return analysis appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 15229850
• Report Number: 2024168-2022-08766
• Device Sequence Number: 17368236
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/14/2022

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: 01/31/2025
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 20215G1
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 88 KG