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

Catalog Number 1012453-12

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

It was reported that a 3.5x38 xience xpedition stent was deployed in the mid right coronary artery (rca) and a 3.25x23 xience xpedition was deployed in the distal rca.The 4.0x33 xience xpedition stent was deployed in the moderately calcified, mildly tortuous lesion in the proximal rca.The nc trek dilatation catheter was inflated four times to post dilate the 4.0x33 stent.After post dilatation, negative pressure was applied to the nc trek, but it became stuck on the guide catheter during removal of the nc trek.After several unsuccessful attempts to remove the nc trek from the guide catheter, all devices (guide catheter, guide wire, nc trek) were removed together as a single unit.After removal of the nc trek from the anatomy, it was noted that the balloon did not refold tightly, which reportedly caused the balloon to get caught on the guide catheter.Another catheter was inserted to take the final shots of the treated artery.There was no adverse patient effect or clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: concomitant medical products: balance middle-weight 190 cm guide wire, medtronic launcher jr4 guide catheter, 3 xience xpedition stents in rca.The device was returned for evaluation.The reported difficulty removing the balloon dilatation catheter from the guide catheter was not confirmed.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 incidents for difficult to remove from the guiding catheter 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: 4208208
• MDR Text Key: 4985803
• Report Number: 2024168-2014-07079
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 10/07/2014

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: 04/30/2015
• Device Catalogue Number: 1012453-12
• Device Lot Number: 30518G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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 Age: 61 YR
• Patient Weight: 59