MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX; CORONARY DILATATION CATHETER

Model Number	1012280-12
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned 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 procedure was performed to treat a lesion in the left main coronary artery common trunk.A 5x12mm trek balloon dilatation catheter (bdc) failed to deflate.The bdc was pulled, and a dissection was noted.The bdc broke [separated] and remained stuck on an unspecified guide wire.The patient then had a bypass surgery.There was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: it was reported that the procedure was performed to treat a lesion in the left main coronary artery common trunk.A 5x12mm trek balloon dilatation catheter (bdc) was advanced without resistance, and the balloon was inflated once to nominal pressure.However, the balloon completely failed to deflate, so the inflated balloon was being removed when it faced resistance during removal with an unspecified 014 guide wire.The bdc shaft separated into two pieces, and a dissection was noted.Unspecified devices were attempted to treat the dissection but failed, so the patient was sent to surgery to remove the separated portion and resolve the dissection.The patient then had bypass surgery and is doing fine now.There was no clinically significant delay in the procedure.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 did not indicate a lot specific quality issue.The reported patient effect of dissection is listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use as a known patient effect of coronary procedures.It is possible that an insufficient amount of time was allowed to deflate the balloon thus compromising the inflation/deflation lumen and the inner member resulting in the reported deflation problem and difficult to remove; however this cannot be confirmed.Manipulation of the device in attempts to remove resulted in the reported material separation.As reported, the patient was sent to surgery to remove the separated portion and resolve the dissection.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10693116
• Report Number: 2024168-2020-08668
• Device Sequence Number: 3058508
• Product Code: LOX
• UDI-Device Identifier: 08717648138775
• UDI-Public: 08717648138775
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 09/30/2022
• Device Model Number: 1012280-12
• Device Catalogue Number: 1012280-12
• Device Lot Number: 91018G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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