MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012272-15

Device Problems Off-Label Use (1494); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/02/2021

Event Type  malfunction  

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.The additional trek balloon referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a calcified renal artery.An attempt to pre-dilate the lesion was made with a 2.50x15mm trek balloon; however, the balloon ruptured at 20 atmospheres (atm).A 3.0x12mm unspecified balloon was used and then the 4.0x15mm trek balloon was attempted to be used however; ruptured at 4 atm.There were no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

H6: device code 2017: above rbp.Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture appears to be related to user error.It was reported by the account that the bdc was overinflated to 20 atmospheres (atms) when the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded.In this case, it is likely the ifu deviation resulted in the reported balloon rupture.Additionally, it was reported that the procedure was to treat a calcified renal artery.It should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, ifu states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: device code 2017: above rbp was added.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12221390
• MDR Text Key: 263431034
• Report Number: 2024168-2021-06428
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: 11/30/2023
• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 01216G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 08/11/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1