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

Catalog Number	1012452-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2016
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.The device was not returned 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.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulties.The 3.75 x 12 mm nc trek referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported the protective sheath was very hard to remove from the nc trek balloons.The 3.75 x 8 mm nc trek was advanced to the target lesion; however, the balloon did not inflate despite the indeflator showing pressure.The device was withdrawn and outside the patient anatomy, the balloon was able to inflate to high pressure.The 3.75 x 12 mm nc trek balloon separated completely during the attempt to remove the stylet.Other devices were used to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints.To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch # 2024168-2017-02310].Corrective action has been implemented per site operating procedures.The product will continue to be trended.The abbott internal recall number is 2024168-3/14/2017-002-r.
Event or Problem Description
Based on return device analysis, the case description was reported incorrectly.It was the 3.75 x 12 mm nc trek with the inflation issue and the 3.75 x 8 mm nc trek had the separation.

• 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: 5948049
• Report Number: 2024168-2016-06069
• Device Sequence Number: 92869
• Product Code: LOX
• UDI-Device Identifier: 08717648152016
• UDI-Public: (01)08717648152016(17)190531(10)60603G1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 05/31/2019
• Device Catalogue Number: 1012452-08
• Device Lot Number: 60603G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1