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

Catalog Number 1012455-08

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported that during a heavily tortuous proximal right coronary artery intervention, after non-abbott stent deployment and post-dilatation, resistance was felt during removal of the 5.0 x 8 mm nc trek balloon dilatation catheter.A guideliner was then inserted to support the removal of the nc trek balloon.The guideliner and nc trek balloon dilatation catheter were removed as a single unit.The cause of the difficulty was attributed to the patient anatomy, but there was also mention of a possible balloon refold issue.There was no adverse patient effect or a clinically significant delay reported.There was no additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported shaft separation and fold issue was confirmed.The reported difficult to remove from vessel could not be replicated in a testing environment as it was based on operational circumstances.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3907536
• MDR Text Key: 4669135
• Report Number: 2024168-2014-04303
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 1012455-08
• Device Lot Number: 30917G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Required Intervention