MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012405-06
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left atrial oblique vein.A 2.5x6mm trek balloon dilatation catheter was advanced without resistance, and the balloon ruptured during the first inflation at 3 atmospheres.An unspecified trek balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported, that the procedure was performed.To treat a lesion in the left atrial oblique vein.A 2.5x6mm trek balloon dilatation catheter was advanced without resistance.And the balloon ruptured, during the first inflation at 3 atmospheres.An unspecified trek balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the device was not immerged in saline, during prep.No additional information was provided.
Additional Manufacturer Narrative
H6: device code 2017 clarifier, incorrect prep.Visual and functional inspections were 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.There was no damage noted, to the balloon catheter prior to use or leak noted, during preparation.Which suggests a product quality issue did not contribute to the reported difficulties.It was reported, that the bdc was not soaked before use.It should be noted, that the coronary dilatation catheters (cdc), mini trek and trek rx, over the wire (otw), global, information for use (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 flap rupture was a result of the device not being soaked, during preparation, because the coating on the balloon was not adequately activated in saline.Such that as the balloon was inflated.The balloon material peeled (noted flap) and ruptured.There is no indication, of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11738551
• Report Number: 2024168-2021-03601
• Device Sequence Number: 14251124
• Product Code: LOX
• UDI-Device Identifier: 08717648153952
• UDI-Public: 08717648153952
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1012405-06
• Device Catalogue Number: 1012405-06
• Device Lot Number: 00520G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1