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

Catalog Number 1012453-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the proximal to mid right coronary artery with moderate tortuosity and moderate calcification.A 4.0x15 nc trek dilatation catheter was prepped per the instructions for use without any issues noted and advanced without resistance for pre-dilatation.When the balloon was deflated, the balloon could not re-wrap to a tri-fold and the distal balloon was bunched.The 4.0x15 nc trek dilatation catheter could not be withdrawn through the non-abbott 6f guide catheter.The guide catheter and dilatation catheter were withdrawn as a single unit from the patient anatomy.A 4.0x15 non-abbott dilatation catheter was used to treat the target lesion.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported balloon refold issue, bunched balloon and resistance with the guiding catheter could not be confirmed.Based on the visual 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 could have contributed to the reported event.A query/review 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.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 3754908
• MDR Text Key: 4480247
• Report Number: 2024168-2014-02383
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/27/2014

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: 11/30/2014
• Device Catalogue Number: 1012453-15
• Device Lot Number: 2121261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: GUIDE CATHETER: LAUNCHER SAL1.0 6F
• Patient Age: 51 YR
• Patient Weight: 87