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

Catalog Number	1012452-15
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2016
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 is not returning for evaluation as it is being retained by the hospital.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that prior to use, the 3.75x15 mm nc trek rx balloon was stuck in the protective sheath; the protective sheath could not be removed and the shaft separated.The nc trek was not used for the procedure.There was no patient involvement and no clinically significant delay in the procedure.An unspecified balloon catheter was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not 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.

• 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: 6178308
• Report Number: 2024168-2016-08903
• Device Sequence Number: 1004087
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: (01)08717648152030(17)190630(10)60726G1
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/01/2017

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: 06/30/2019
• Device Catalogue Number: 1012452-15
• Device Lot Number: 60726G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 04/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1