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

Catalog Number 1012447-12

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date of event.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that before use when the protective sheath was removed from the nc trek rx 2.5 x 12 mm balloon dilatation catheter there was no difficulty or resistance; however, the balloon made a bursting noise and the balloon looked burst although it was not touched.The device was not used in the patient anatomy.The procedure was completed using another unspecified balloon.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported torn material (balloon) was not confirmed and the reported device operated differently (noise) could not be replicated in a testing environment as it was based on operational circumstances.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.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 6807595
• MDR Text Key: 83305256
• Report Number: 2024168-2017-06818
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 1012447-12
• Device Lot Number: 60505G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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