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

Model Number	1012454-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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 vein graft to the circumflex artery.A 6f guide catheter and a 190cm balance guide wire was used.A 4.00x38mm xience skypoint was advanced and deployed and then a 4.5x33 mm xience skypoint stent was deployed and the 4.50x12mm nc trek balloon dilatation catheter (bdc) was used for post dilatation of both stents.For the 1st and 2nd inflation the balloon was inflated to 15 atmospheres (atm) for 10 seconds and then for the 3rd, 4th and 5th inflation to 17 atm for 10 seconds.During removal of the balloon the tip of the balloon broke off, therefore the bdc was removed as a single unit with guide catheter and wire.The sheath was then exchanged to a larger 7fsheath in order to snare the tip of the balloon from the patient using a 7f snare.There was no adverse patient sequela.The patient is doing fine and there was no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 tip separation; however, factors that may contribute to material separation (tip) include, but are not limited to, processing and/or handling in manufacturing, handling during preparation for use, inadvertent mishandling during use, lesion characteristics, procedural technique, severe torquing or kinking (material stress/ fatigue) or interaction with the accessory devices, lesion and/or anatomy.The tip was successfully snared with no adverse patient effect.The reported treatments appear to be related to operational context of the procedure.It should be noted there was no reported damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15762341
• Report Number: 2024168-2022-11434
• Device Sequence Number: 8229286
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: 08717648152108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 04/30/2025
• Device Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 20517G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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: 4.00X38MM XIENCE SKYPOINT; 6FR GUIDE CATHETER; BALANCE GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 111 KG