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

Catalog Number 1012274-20

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.In this case, it is possible that the device was inadvertently mishandled and/or removed at an angle during unpacking at the account resulting in the reported separation; however, since the device was not returned for analysis and limited information was provided, a conclusive cause cannot be determined.The investigation was unable to determine a conclusive cause for the reported separation.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that during packaging removal, the tip of a 3x20mm trek balloon dilatation catheter (bdc) separated.The device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.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: 9490984
• MDR Text Key: 178117434
• Report Number: 2024168-2019-14704
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012274-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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