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

Catalog Number 1012451-20

Device Problems Difficult to Remove (1528); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.Investigation is not yet complete.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during preparation for use, the sheath of a 3.5x20mm nc trek balloon dilatation catheter would not come off of the balloon.The device was not used.There was no clinically significant delay in the procedure, and a new balloon was used to successfully complete the procedure.While gathering the information to report the incident, it was noted that the lot number printed in the product was 40506g1, but the lot number printed on the package was 40506ga.No additional information was provided.

Manufacturer Narrative

(b)(4).Device was not returned.(b)(4).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.The review revealed that this device was part of a rework to extend the expiration date of the lot to 30/april/2017.Lot number 40506ga (on the packaging) is the rework label of lot number 40506g1 (on the product).To preserve sterility of the product, only the outer packaging labels are replaced when the lot is reworked.As such, there is no indication of a labeling issue.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath and no failure was detected with the reported labeling 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.

Manufacturer Narrative

(b)(4).It was initially reported that the device would not be returning for analysis; however, the device has been received.Evaluation summary: the device was returned for analysis and the reported resistance to remove the balloon protective sheath was confirmed.The inner diameter of the sheath met specification.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device's performance with regards to the difficulty with removing the protective sheath appear to be related to normal variation found in manufacturing.The performance of these devices will continue to be monitored.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5693512
• MDR Text Key: 46465448
• Report Number: 2024168-2016-03521
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 1012451-20
• Device Lot Number: 40506GA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2016; 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1