MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012272-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Angina (1710); Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the left anterior descending artery.The 2.5x20mm trek rx balloon dilatation catheter was prepared per the instructions for use without issues; however, the balloon ruptured during the fourth inflation at 6-8 atmospheres.The procedure was successfully completed with the deployment of a 2.5x28mm unspecified stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The reported patient effects of angina, hypotension and dissection are listed in the coronary dilatation catheters, trek rx and mini trek rx, instructions for use as known patient effects.The investigation determined the reported balloon rupture, additional treatment and hospitalization appear to be related to operational context.A conclusive cause for the reported patient effects of angina, hypotension, and dissection and the relationship to the device, if any, cannot be determined.Attachment: user medwatch report #5099477 b1, b2, h1: malfunction to serious injury.H6: health effect - impact code 2199 removed.Investigation conclusions code 4307 removed.
Event or Problem Description
Additional information: user facility medwatch report received that states: a (b)(6) yo f undergoing pci to the proximal to mid diagonal branch complicated by balloon rutpure (abbott balloon trek 2.5x20mm ref number: 1012272-20 lot#: 00420g1 exp: 2023-03-31) during low-pressure angioplasty and subsequent dissection propagating proximally.This was successfully contained and treated with appointment of 2 overlapping xience sierra drug-eluting stents.Patient c/o chest pain and experienced hypotension, put in a couple stents to fix the problem.Patient was addmitted for overnight stay and discharged on (b)(6) 2021 at her baseline.Fda safety report id #(b)(4).

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11418181
• Report Number: 2024168-2021-01729
• Device Sequence Number: 17102698
• Product Code: LOX
• UDI-Device Identifier: 08717648138300
• UDI-Public: 08717648138300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 03/31/2023
• Device Model Number: 1012272-20
• Device Catalogue Number: 1012272-20
• Device Lot Number: 00420G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR