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

Model Number	1012445-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 treating a target lesion in the left circumflex (cx) artery.While advancing the 2.0 x 15 mm nc trek through the guide catheter, it was noted that there were two additional interventional wires in the guide catheter, along with the nc trek.Although no resistance was noted, during advancement, the nc trek dilatation catheter separated into two segments, at the distal segment, where the inflation device attaches.The separated segments were easily removed and a second nc trek dilatation catheter was used.There was no adverse patient effect and no clinically significant delay.There was no additional information provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able 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 from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling and/or interaction with the guiding catheter/two additional interventional wires in the guide catheter resulted in the noted wrinkled inner member/outer member/balloon and ultimately resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 10530037
• Report Number: 2024168-2020-07668
• Device Sequence Number: 3336393
• Product Code: LOX
• UDI-Device Identifier: 08717648151651
• UDI-Public: 08717648151651
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 11/30/2020
• Device Model Number: 1012445-15
• Device Catalogue Number: 1012445-15
• Device Lot Number: 71211G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 80