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

Model Number	1012454-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation determined the reported complaint and additional treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
This is being filed to report that after use with the nc trek balloon catheter, the distal portion of the catheter separated in the anatomy, during removal requiring medical intervention.It was reported that the procedure was performed to treat a lesion with heavy calcification in obtuse marginal coronary artery.The 4.5 x 20 mm nc trek balloon catheter was advanced to the target lesion but there was resistance due to the heavy calcification.When the nc trek balloon catheter was being removed there was resistance and the distal portion of the catheter separated in the anatomy.The separated distal portion remained on the guide wire.A snare was used to retrieve the separated portion.There was no resistance noted during removal of the balloon catheter.A new nc trek balloon catheter was advanced to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• 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: 11886647
• Report Number: 2024168-2021-04421
• Device Sequence Number: 1266224
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 01003G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 88