MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012449-15
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the anterior descending artery.The 3.0x15mm nc trek balloon dilatation catheter (bdc) and the ht balance middleweight universal ii (bmw) guide wire were positioned together.It was noted the bdc met resistance with anatomy during advancement.During removal the balloon was observed to be stuck in the distal part of the bmw universal ii guide wire.Both devices were removed together as one unit.After the procedure the balloon was removed from the guide wire and it was noted that the distal hydrophilic layer of the guide wire was lost.It was perceptible to the touch.There was no clinically significant delay reported.No additional information was provided.
Additional 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 ht balance middleweight universal ii (bmw) guide wire referenced is filed under a separate medwatch report number.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the guide wire; however, the reported difficulty advancing the device in the anatomy appears to be related to operational context.Factors that may contribute to the difficult advancing and removing the balloon dilatation catheter (bdc) from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.Additionally, it was reported by the account that the bdc interacted with the anatomy resulting in the reported difficulty advancing the device.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15336660
• Report Number: 2024168-2022-09308
• Device Sequence Number: 6927922
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: 08717648151873
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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 Model Number: 1012449-15
• Device Catalogue Number: 1012449-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HT BMW UNIVERSAL II GUIDE WIRE
• Patient Sex: Unknown