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	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned.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 2024168-3/14/2017-002r.
Event or Problem Description
It was reported that the nc trek was prepared for use.The protective sheath was difficult to remove; however, it was able to be removed and the device was used.The patient underwent a coronary procedure to treat a target lesion in the left anterior descending (lad) artery.The nc trek dilatation catheter balloon was inflated, at the lesion, without issue, but the balloon could not be deflated.A non-abbott inflation device was used and then replaced with a 20 cc syringe and a 30 cc syringe.The balloon would not deflate.The physician finally broke the dilatation catheter shaft at a location outside the patient anatomy and the balloon deflated.The device was removed without difficulty and there was no adverse patient effect.There was no clinically significant delay.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: 6437226
• Report Number: 2024168-2017-02549
• Device Sequence Number: 13590942
• Product Code: LOX
• UDI-Device Identifier: 08717648151804
• UDI-Public: (01)08717648151804(17)190831(10)60906G1
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Recall
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1012448-08
• Device Lot Number: 60906G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: COMET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 94