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

Model Number	1012449-08
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
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 to treat a 90% stenosed, mildly calcified, and mildly tortuous de novo lesion in the left anterior descending artery.A 3.00mm x 8mm nc trek balloon dilatation catheter (bdc) was advanced for post-dilatation; however, the balloon failed to inflate and a leak at the proximal shaft was noted.The balloon was removed and a new 3.00mm x 8mm nc trek bdc was used to successfully complete the procedure.There were no adverse patient effects reported and no significant delay in the procedure reported.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported leak and inflation 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 report of a leak during preparation (air aspiration) for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after preparation inadvertent mishandling resulted in the noted separated hypotube at the distal end of the hub; thus resulting in the reported leak and inflation problem.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: 10112855
• Report Number: 2024168-2020-04698
• Device Sequence Number: 3817073
• Product Code: LOX
• UDI-Device Identifier: 08717648151859
• UDI-Public: 08717648151859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/25/2020

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: 10/31/2022
• Device Model Number: 1012449-08
• Device Catalogue Number: 1012449-08
• Device Lot Number: 91111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1