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

Catalog Number 1012449-15

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was performed to treat the left main artery.A 3.0 x 15 mm nc trek balloon dilatation catheter (bdc) was prepared for use.The outer box was labeled as a 3.0x15 mm nc trek bdc.However, the actual device inside the box was a 3.5x15 mm nc trek bdc.Although the issue was discovered during preparation, a decision was made to use the bdc.The bdc successfully treated the target lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Patient codes: 2645 labeled na.Internal file number (b)(4).Patient code 2199 and device code 2017 removed.Patient code 2645 added.Evaluation summary: a visual inspection was performed on the returned device.The reported complaint was 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 complaint appears to be related to operational context as it is likely a mix-up occurred at the hospital.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of this device.

Event Description

Subsequent to the initially filed report, the following information was received: the balloon dilatation catheter was not used in the patient.There was no patient involvement.No additional information was provided.

• 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: 8709084
• MDR Text Key: 148337766
• Report Number: 2024168-2019-04815
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 1012449-15
• Device Lot Number: 90211G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1