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

Model Number	1012452-20
Medical Device Problem Codes	Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter, and nc traveler coronary dilatation catheter.The field safety action number is (b)(4).This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.
Event or Problem Description
It was reported that during preparation of the 3.75x20mm nc trek balloon dilatation catheter (bdc), difficulty was experienced in removing the protective sheath.The bdc was advanced to the 70% stenosed mid to proximal right coronary artery (rca) for post-dilatation.The bdc was inflated 3 times to 20 kilopascal-pressure-units (kpa), and negative was held for 5 seconds, but the balloon would not fully deflate, or refold tightly enough to be pulled back into the guiding catheter, so the guide wire, guide catheter, and partially deflated balloon were removed as a single unit.There was no adverse patient effect, or a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deflation problem was not confirmed as the device inflated and deflated as intended.The reported difficult to remove-anatomy was unable to be replicated in a testing environment as it was based on operational circumstances.The reported failure to fold was able to be confirmed.The reported difficult to remove-protective sheath was unable to be confirmed as the sheath was not returned.Additionally, it was noted that the outer member (om) and inner member (im) were stretched and the im was collapsed.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.It should be noted that the nc trek rx coronary dilatation catheter instructions for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).Rbp for the nc trek rx 3.75 x 20mm is 18 atm.The deviation of the ifu does not appear to have contributed to the reported difficulties.The investigation determined the reported deflation problem, difficult to remove-anatomy and failure to fold appear to be related to circumstances of the procedure as it is likely that an sufficient time was not allowed to fully deflate the balloon before an attempt was made to remove the device resulting in the noted stretched outer member and inner member and collapsed inner member; thereby reducing the inflation/deflation lumen thus resulting in the reported deflation problem, difficult to remove and failure to fold.Additionally, it is possible inadvertent mishandling resulted in the reported difficult to remove-protective sheath however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult to remove-protective sheath difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 10680821
• Report Number: 2024168-2020-08600
• Device Sequence Number: 19610444
• Product Code: LOX
• UDI-Device Identifier: 08717648152047
• UDI-Public: 08717648152047
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 08/31/2022
• Device Model Number: 1012452-20
• Device Catalogue Number: 1012452-20
• Device Lot Number: 90922G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1133- 2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC JR4.0 6F