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

Catalog Number 1012449-25

Device Problems Inflation Problem (1310); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

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.

Event Description

It was reported, the 3.0x25mm nc trek balloon dilatation catheter (bdc) was used to pre-dilate the lesion.The same nc trek (bdc) was used again for post-dilatation.The nc trek (bdc) was inflated to rated balloon pressure (18 atmospheres)however, the balloon fully inflated except at the area of constriction; a section of the balloon seemed twisted.The nc trek bdc was replaced with a non-abbott bdc to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

(b)(4).Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed; however, the outer member was twisted at the proximal seal.The cine of the event was received and reviewed by an abbott clinical specialist who noted the twisted nc trek rx balloon catheter was confirmed angiographically.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.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.The investigation was unable to determine a conclusive cause for the reported difficulties.

• 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: 5694669
• MDR Text Key: 46466962
• Report Number: 2024168-2016-03531
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2016

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: 04/30/2018
• Device Catalogue Number: 1012449-25
• Device Lot Number: 50513G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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