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

Catalog Number 1013067-15

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous mid left anterior descending artery.The 2.50x15mm traveler balloon dilatation catheter (bdc) met resistance during advancement with the anatomy.The bdc ruptured during the first inflation at 5 atmospheres.A non-abbott device was used to successfully perform dilatation and then an unspecified stent was implanted to 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 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 incidents reported from this lot.In this case, the device was prepped prior to use without any issue 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 case circumstances of the procedure.Based on the reported information, during advancement, the balloon catheter encountered resistance with the challenging anatomy resulting in the difficulty to advance.The difficulty to advance likely caused damage to the outer surface of the balloon resulting in the reported balloon rupture during the first inflation at 5 atmospheres.There is no indication of a product quality issue with respect to manufacture, design.Or labeling.The traveler rx device is currently not commercially available in the us; however, it is similar to a device sold in the us.

• Brand Name: TRAVELER 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: 12911308
• MDR Text Key: 283304924
• Report Number: 2024168-2021-10940
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 1013067-15
• Device Lot Number: 00106G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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