MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012452-08
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Guide wire: runthrough.Guide cath: mach1.Stent: xience sierra.The 2.75x15 mm xience sierra referenced is being filed under a separate medwatch report.The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on review of the similar incidents, there is no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information it is likely that during advancement the balloon catheter interacted with the heavily calcified, heavily tortuous anatomy causing the reported failure to advance and resistance removing.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Event or Problem Description
It was reported that the procedure was to treat a de novo, heavily calcified, eccentric lesion in the heavily tortuous, proximal right coronary artery.A 2.75x15 mm xience sierra stent was implanted and after confirmation with intravascular ultrasound (ivus), the stent was found to be mal-apposed.There were no other issues noted with the xience sierra stent.A 3.75x8 mm nc trek balloon dilatation catheter (bdc) was used for post dilatation; however, the bdc could not cross the lesion due to resistance with the lesion.Resistance was felt with the lesion during removal of the bdc.No damage was noted to the nc trek bdc.A non-abbott bdc was used to complete the procedure and the xience sierra was fully apposed to the vessel wall.No damage was noted to the stent implant.There were no adverse patient effects and no reported 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): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8026679
• Report Number: 2024168-2018-08335
• Device Sequence Number: 1407503
• Product Code: LOX
• UDI-Device Identifier: 08717648152016
• UDI-Public: 08717648152016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: 01/31/2020
• Device Catalogue Number: 1012452-08
• Device Lot Number: 70208G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1