MAUDE Adverse Event Report: ABBOTT VASCULAR INC. TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012274-12
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported the procedure was to treat a lesion in the left anterior descending (lad) artery.The 3.0x12mm rx trek balloon dilatation catheter (bdc) was used for post dilatation of a stent however the balloon ruptured and did not deflate.An attempt was made to remove the bdc however the shaft broke and the separated portion remained stuck inside the lad.The patient was sent for emergency surgery however the patient expired.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The reported patient effect of death is listed in the trek rx instruction for use (ifu) as a known patient effect of coronary procedures.It was reported that the balloon dilatation catheter (bdc) ruptured and would not deflate.Factors that may contribute to a material rupture include, but are not limited to, material damage, inflation technique, interactions with other devices, lesion calcification and tortuosity, or insufficient preparation prior to use.Factors that may contribute to a deflation problem include, but are not limited to, inflation/deflation technique, contrast concentration, contamination in the inflation lumen, or inflation lumen.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material rupture and deflation problem.Additionally, it was reported that the balloon became entrapped within the anatomy and separated.A balloon that has failed to deflate would have reduced clearance with the anatomy and accessory devices, possibly contributing to the reported entrapment.Manipulation of the bdc when the entrapment occurred possibly contributed to the reported material separation; however, this cannot be confirmed.The separated portion of the bdc was attempted to be removed through surgery; however, the patient expired.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Additionally, a medical reviewer examined the details of this case.This was a case of post-dilating an unknown stent that had been deployed in the left anterior descending artery (lad).The balloon reportedly ruptured at an unreported atm pressure and did not deflate.The provided image shows what appears to be an inflated balloon and no evidence of a rupture is apparent.It was not reported why it was thought that the balloon ruptured and did not deflate.The best practice to remove an inflated or partially inflated balloon is to remove the entire system as a whole.Another method is to slowly re-inflate the balloon to its nominal pressure and then deflate the balloon by holding negative pressure for 15-30 seconds, depending on the size of the balloon.After holding negative for 15-30 seconds, then gently attempt to remove the balloon.If the balloon does not move, and the patient is in a stable condition, repeat the slow nominal inflation/deflation and gentle removal attempts; if those fail, remove the entire system as a whole.It was reported that the attempts to remove the balloon were unsuccessful, which led to the balloon catheter separating, leaving the distal portion of the catheter and inflated balloon within the lad.The patient was sent to surgery to have the retained balloon catheter removed.However, the patient expired.It was not reported when the patient expired.Due to the limited information provided, it can be definitively stated that the trek rx 3.0 x 12 balloon dilatation catheter most likely caused or contributed to this patient¿s death due to the separation of the balloon catheter and subsequent occlusion of the lad.

• Brand Name: TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19719994
• Report Number: 2024168-2024-08171
• Device Sequence Number: 8207046
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: (01)08717648138423(17)251031(10)21122G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 10/31/2025
• Device Model Number: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 21122G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2022
• 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: Death
• Patient Sex: Male