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

Model Number	1012433-20
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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.The balance middleweight universal guide wire device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified, mildly tortuous left coronary artery.A 2.0x20mm otw nc trek balloon dilatation catheter was advanced over a balance middleweight universal guide wire with resistance noted.The devices got twisted and subsequently got stuck with each other.During removal, the guide wire tip separated.The distal portion of the separated guide wire was simply removed with the nc trek as a single unit.A new unspecified balloon catheter and guide wire were used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device and the reported difficult to advance/position and difficult to remove the wire were unable to be confirmed.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 incidents reported from this lot.The investigation determined the reported difficulty to advance/position and difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement of the balloon dilatation catheter (bdc) encountered resistance with the heavily calcified, mildly tortuous anatomy resulting in the difficulty to advance/position the device over the wire.Additional manipulation during advancement likely caused devices to become twisted over each other resulting in the difficulty to remove.The noted kinks and bends on the device likely occurred during the procedure or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Changed part number from 1012433-20 to 1012445-20.
Event or Problem Description
Additional information received on 1/17/2020: the 2.0x20mm nc trek was an rx not an otw.The bmw universal was actually a bmw universal ii.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9516933
• Report Number: 2024168-2019-14970
• Device Sequence Number: 14318144
• Product Code: LOX
• UDI-Device Identifier: 08717648151064
• UDI-Public: 08717648151064
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 05/31/2022
• Device Model Number: 1012433-20
• Device Catalogue Number: 1012445-20
• Device Lot Number: 90620G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMW UNIVERSAL; BMW UNIVERSAL II