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

Model Number	1012273-20
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident information was reviewed; however, the product was not returned to abbott vascular 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 identified no other similar incidents reported from this lot.In this case, the device was prepped prior to use without issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported difficulty to advance and balloon rupture appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement the balloon catheter encountered resistance the 90% stenosed and moderately tortuous anatomy.It is likely that with the multiple inflations the balloon became weak or damaged against the anatomy resulting in the low balloon rupture during the third inflation.The balloon was inflated twice prior to the balloon rupture without any issues noted.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a 90% stenosed and moderately tortuous lesion in the distal right coronary artery.A 2.75x20mm trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was being used for pre-dilatation and during advancement resistance with the anatomy was felt.Once at the lesion site, the balloon ruptured during the third inflation at 12 atmospheres.The dilatation was sufficient and the procedure was successfully completed with the deployment of an unspecified stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX TREK
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9955736
• Report Number: 2024168-2020-03626
• Device Sequence Number: 2718260
• Product Code: LOX
• UDI-Device Identifier: 08717648138379
• UDI-Public: 08717648138379
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

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 Expiration Date: 01/31/2021
• Device Model Number: 1012273-20
• Device Catalogue Number: 1012273-20
• Device Lot Number: 80209G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1