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

Model Number	1012453-08
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was brought to cardiac cath lab (ccl) from emergency department (ed) in an emergent setting.Verbal consent was obtained.Patient explained of all risks and agreed to proceed.Per doctor's notes: post-intervention with drug eluting stent (des), a non-compliant (nc) balloon was inserted.During inflation this balloon ruptured and ended up migrating into the proximal-mid left anterior descending artery (lad), and required retrieval via guideliner and balloon with pullback, which was performed successfully by trapping this ruptured balloon.Per registered nurse (rn) report: product: abbott non-compliant coronary dilation catheter, size 4.0 x 8.0 mm.Balloon was being inflated in coronary artery and ruptured during inflation.Balloon was well below the rate of burst pressure and device snapped off at the shaft at the midpoint of the balloon.Approximately 7mm of the distal shaft and the distal half of the balloon broke off and was stuck in the left anterior descending artery.Pieces were safely retrieved, and the case finished without patient harm.Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, nc trek (per site reporter).Ccl manager called and spoke to field representative.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd; temecula CA 92591
• MDR Report Key: 19191634
• Report Number: 19191634
• Device Sequence Number: 18249351
• Product Code: LOX
• UDI-Device Identifier: 08717648152054
• UDI-Public: (01)08717648152054(17)260131(10)3022G1(91)6404
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023
• Report Date (Section F): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012453-08
• Device Catalogue Number: 1012453-08
• Device Lot Number: 3022G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: White
• Date Report Sent to FDA: 12/21/2023