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

Model Number	1012403-06A
Medical Device Problem Codes	Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Na.
Event or Problem Description
It was reported that a 2.00x6mm mini trek ii otw balloon dilatation catheter leaked during preparation.The device was not used and there was no patient involvement.The procedure was successfully completed with an unspecified device.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code - 1494 - indication for use.Visual and functional inspections were performed on the returned device.The reported leak 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 incidents and/or complaints from this lot.It was reported that the procedure was performed to treat a left arterial flutter.It should be noted the coronary dilatation catheters, mini trek ii over the wire (otw), global, instruction for use (ifu) states: the mini trek ii otw coronary dilatation catheter is 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, balloon dilatation of de novo chronic total coronary occlusions.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation was unbale to determine a conclusive cause for the reported leak.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.Return analysis noted flaps of peeled balloon material in the fold at the leak area in the balloon and additional areas of peeling/scratched material near the noted balloon flap rupture.In this case, it is likely that during preparation for use, the coating on the balloon was not adequately activated in saline such that as the balloon was inflated, the balloon material peeled (noted flap), which resulted in the reported leak and noted balloon rupture; however, since limited information was reported, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B5: event description.B6 - relevant test/laboratory data.B7 - other relevant history.H6: health effect - impact code 2645 removed.
Event or Problem Description
The following corrected event description was received stating: the procedure was performed to treat a left arterial flutter.The 2.00x6mm mini trek ii otw balloon dilatation catheter leaked during use.There were no adverse patient effects.No additional information was provided.

• Brand Name: MINI TREK II OTW CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11896061
• Report Number: 2024168-2021-04464
• Device Sequence Number: 16497293
• Product Code: LOX
• UDI-Device Identifier: 08717648180859
• UDI-Public: 08717648180859
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 11/30/2023
• Device Model Number: 1012403-06A
• Device Catalogue Number: 1012403-06A
• Device Lot Number: 01202G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1