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

Model Number 1012274-20

Device Problems Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Pericardial Effusion (3271)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous, and moderately calcified lesion in the right coronary artery.Reportedly, the 3.00x20mm trek rx balloon dilatation catheter (bdc) was not soaked prior to use.The bdc was used to pre-dilate the lesion and was inflated once at 17 atmospheres (atm); however, a balloon rupture occurred at 16 atm.The bdc could be deflated without problems, but during retrieval a piece of balloon remained in the vessel.The separated balloon piece was pressed against the vessel wall with a stent.The patient became unstable through the entire procedure (vascular occlusion, pericardial effusion and emergency surgery).The patient was transferred to another hospital for bypass surgery.Patient is fine.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported balloon rupture and separations were confirmed.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/complaints from this lot.The investigation determined the reported balloon rupture appears to be related to user error/operational context as it was reported that the balloon was not soaked prior to use and that it inflated above rated burst pressure (rbp) to 16 atmospheres (atm).It should be noted that the coronary dilatation catheters, trek rx and mini trek rx, global, instruction for use states: balloon pressure should not exceed the rbp.The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded.Additionally, the ifu states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is likely that the violations to the ifu contributed to the reported balloon rupture as it is likely that the rupture resulted from the device not being properly prepped because the coating on the balloon was not adequately activated in saline such that when the balloon was overinflated, it ruptured.Furthermore, the balloon likely interacted with the anatomy and/or accessory device at the ruptured location and ultimately separated during removal.Therefore, the investigation determined the reported separation, device embedded, surgical procedure, additional treatment and hospitalization appear to be related to circumstances of the procedure.The reported patient effect of occlusion is listed in the ifu as a known patient effect.A conclusive cause for the reported patient effects of occlusion and pericardial effusion and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: RX TREK
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9643078
• MDR Text Key: 176832461
• Report Number: 2024168-2020-00974
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 90913G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability