MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-12
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the patient was admitted with myocardial infarction.Angiography noted that the mid right coronary artery (rca) was 100% occluded with clot, and the rca ostium was 99% occluded.A non-abbott guide catheter extension was used.Stenting was performed using non-abbott stents.The 4.0 x 12 mm trek dilatation catheter was advanced for post dilatation of a non-abbott stent.The balloon was inflated without issue and was thought to be deflated without issue.An attempt was made to remove the trek dilatation catheter; however, it was noted that the balloon remained partially inflated and separated in the anatomy.It is unknown what caused the balloon separation; however, it was reported that during the procedure, when the guide catheter extension was removed, some of the non-abbott stent struts became flared.An attempt was made to remove the balloon; however, this was unsuccessful.The plan was made to possibly send the patient for surgical intervention.The patient was transferred to his room and was in stable condition.There was good blood flow around the separated balloon segment.The patient will undergo catheterization on (b)(6) 2021, and the decision will be made if additional intervention is required.No additional information was provided.
Additional Manufacturer Narrative
Nah6 type of investigation code 4114 (device not returned) - removed.
Event or Problem Description
User facility medwatch report (uf/importer report# 4400150000-2021-8028) received that states: "during percutaneous transluminal coronary angioplasty (ptca) of right coronary artery (rca), a coronary dilatation balloon broke off at the shaft and was left in the patient's rca.The device was a trek rx 4.00mm x 12mm balloon.Ct surgery was called in to evaluate the patient.Plan is to correct surgically.".
Additional 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.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device, balloon separation, additional treatment, surgical procedure.Hospitalization and foreign body in patient appear 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.
Event or Problem Description
Subsequent to the initial report, additional information was received.On (b)(6) 2021, the patient underwent a surgical procedure to remove the separated balloon segment.A portion of the separated balloon segment remains in the patient anatomy.The patient is in stable condition.No additional information was provided.

• Brand Name: 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: 12544321
• Report Number: 2024168-2021-08709
• Device Sequence Number: 17436739
• Product Code: LOX
• UDI-Device Identifier: 08717648138706
• UDI-Public: 08717648138706
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2022

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: 07/31/2023
• Device Model Number: 1012278-12
• Device Catalogue Number: 1012278-12
• Device Lot Number: 00813G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 01/12/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/05/2021; 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG