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

Catalog Number 1012268-06

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 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 leak or ruptures noted, which would suggest that the device was not damaged prior to use.It should be noted that the mini trek rx, global, instructions for use states: slide the protective sheath off the balloon.Note: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating.In this case, the reported ifu violation does not appear to have caused or contributed to the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.In this case, it is likely that during inflation the balloon became compromised and/or damaged against the 99% stenoses anatomy resulting in the balloon rupture at 12 atmospheres.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.

Event Description

It was reported that the procedure was performed to treat a lesion with 99% stenosis in the right coronary artery.Prior to use, a 1.20 x 6mm mini trek balloon dilatation catheter (bdc) was not soaked in saline.While pre-dilatation was being performed, the balloon of the bdc ruptured during first inflation at 12 atmospheres.The bdc was simply removed and another same size trek bdc was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MINI TREK 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: 10744499
• MDR Text Key: 213692413
• Report Number: 2024168-2020-08953
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 1012268-06
• Device Lot Number: 91104G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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