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

Model Number 1012272-15

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 was unable to determine a conclusive cause for the reported complaints since the device was not returned for analysis and limited information was provided.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 prior to use, the 2.50x15mm rx trek balloon dilatation catheter was pressurized outside of the patient and a puncture was noted.A leak was noted from the puncture.The location of the puncture was not specified.There was no patient involvement.A new unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device returned for analysis.The reported leak and the reported material split, cut or torn were able to be confirmed.As there was no report of a leak during preparation for use and there was noted blood inside the guide wire lumen and in the balloon folds consistent with advancement, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3 - it was initially reported that the device would not be returning for analysis.Subsequent information revealed that the device was returned for evaluation.Method code 4114 was removed.Conclusion code 67 was removed.

• Brand Name: TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9938443
• MDR Text Key: 187069029
• Report Number: 2024168-2020-03500
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138294
• UDI-Public: 08717648138294
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 71207G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1