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

Catalog Number 1012451-20

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during the procedure, treating a target lesion in the mid right coronary artery, the 3.5 x 20 mm nc trek balloon dilatation catheter (bdc) was advanced over a guide wire.When advancing through the hemostatic valve, the nc trek catheter kinked and separated at the hub and was removed without difficulty.It was reported that there was no resistance noted when advancing over the guide wire or through the hemostatic valve.A new same size nc trek was used over the same guide wire and advanced through the same hemostatic valve without difficulty.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: a visual inspection was performed on the returned device and the shaft kink and separation were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported/noted difficulties of shaft kinks and shaft separation appear to be related to circumstances of the procedure.Based on the reported information, it is likely that manipulation and/or inadvertent mishandling of the device during advancement through the hemostatic valve caused the device to kink resulting in the separation.The hypotube and strain relief fractured faces at the separation were ovalled as if kinked prior to separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 8214491
• MDR Text Key: 131986401
• Report Number: 2024168-2019-00046
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 1012451-20
• Device Lot Number: 81016G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2018
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 50