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

Catalog Number	1012448-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual and dimensional inspections were performed on the returned device.The shaft separation was confirmed.The difficulty positioning and removing of the device could not be replicated in a testing environment as it was based on operational circumstances.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 from this lot.The investigation determined the reported difficulties 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
It was reported that the procedure was to treat a lesion in the heavily calcified, heavily tortuous, proximal circumflex coronary artery.A non-abbott stent was implanted.When advancing a 2.75x08mm nc tek balloon dilatation catheter (bdc), for post dilatation; resistance was felt with the guiding catheter.When removing the bdc from the guiding catheter resistance was felt with the guide catheter and the distal shaft separated in the guide catheter.The distal shaft was removed from the guide catheter by hand and another nc trek bdc was used to complete the procedure.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the core failure may be attributed to ductile overload at a bend.The fracture surface revealed dimples, small pits and smearing.The outer and inner surfaces were documented as requested.Surface cracks were observed.There was no damage noted to the bdc prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 7297373
• Report Number: 2024168-2018-01386
• Device Sequence Number: 11072028
• Product Code: LOX
• UDI-Device Identifier: 08717648151804
• UDI-Public: 08717648151804
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 08/31/2018
• Device Catalogue Number: 1012448-08
• Device Lot Number: 50904G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1