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

Catalog Number 1012269-12

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.Visual and functional inspections were performed on the returned device.The reported loose or intermittent connection was not confirmed.However, a proxy indeflator, filled with water, was used to pressurize the balloon when fluid leaked out of the noted crack at the proximal end of the hub.In this case, it is possible that the inflation device was over torqued during attempts to connect to the hub of the device, resulting in the noted cracks, chipped off threading of the luer, leak and subsequently the reported loose or intermittent connection.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 and/or complaints from this lot.The investigation determined the reported difficulty 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 this device.

Event Description

It was reported that a 1.50x12mm mini trek rx balloon dilatation catheter (bdc) was not able to connect properly to an indeflator.The bdc was not used.The procedure was successfully completed with an unspecified bdc.There was no patient involvement and there was no clinically significant delay in the procedure.The return device analysis identified that a portion of the threading on the luer was chipped off and that there was a leak at the noted crack on the hub.No additional information was provided.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 9507094
• MDR Text Key: 178334257
• Report Number: 2024168-2019-14873
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138096
• UDI-Public: 08717648138096
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 1012269-12
• Device Lot Number: 90713G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1