MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-15

Device Problem Inflation Problem (1310)

Patient Problem No Code Available (3191)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional devices referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was performed to treat a lesion in the right coronary artery.The following balloon dilatation catheters (bdc) (3x15mm nc trek, 3x15mm trek, and 2x15mm mini trek) were used in the patient in the same procedure.All three bdcs failed to inflate, and there was an unknown serious injury that may be related to the devices.An unspecified stent was used to successfully complete the procedure.Reportedly, there was no adverse patient sequelae and no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was performed to treat a lesion in the right coronary artery.The following balloon dilatation catheters (bdc) (3x15mm nc trek, 3x15mm trek, and 2x15mm mini trek) were used in the patient in the same procedure.All three bdcs failed to inflate, and there was an unknown serious injury that may be related to the devices.An unspecified stent was used to successfully complete the procedure.Reportedly, there was no adverse patient sequelae and no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the following balloon dilatation catheters (bdc) (3x15mm nc trek, 3x15mm trek, and 2x15mm mini trek) failed to inflate and delayed the procedure, but the balloons did not contribute to any patient harm.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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 complaint from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B1: adverse event removed.B2: outcomes attributed to ae updated from "other serious" to "na." h1: type of reportable event changed from serious injury to malfunction.H6: health effect, impact code 3191.Na was removed and code 2199.Na 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: 11132214
• MDR Text Key: 225538429
• Report Number: 2024168-2021-00203
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138430
• UDI-Public: 08717648138430
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1012274-15
• Device Catalogue Number: 1012274-15
• Device Lot Number: 91128G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other