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

Catalog Number 1012448-15

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event - estimated.(b)(4).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 during an intervention, when the nc trek balloon dilatation catheter entered into the patient, the physician recognized that there was no balloon crimped on the hypotube.The device was removed and another balloon catheter was used to finish the procedure.It did not fall off, nor was lost in the patient, or in the sheath, it was simply missing completely.The physician did not inspect the device thoroughly before use, so he realized it when the device was already in the patient.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1562 not labeled.Internal file number - (b)(4).Correction: device code 2306 - not labeled - removed.Evaluation summary: visual inspection was performed on the returned device.The reported separation was confirmed.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: prior to use examine all equipment carefully for defects.Do not use any defective equipment.In this case, the reported violation does not appear to have caused or contributed to the complaint.The complaint investigation determined the reported difficulty is related to manufacturing issues associated with the protective sheath.Abbott vascular will continue to trend the performance of these devices.On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.The abbott internal recall number is (b)(4) and documented in viper number (b)(4).

Event Description

Subsequent to the initial 30-day medwatch report, it was reported that there was no resistance removing the protective sheath.The device was prepped normally.The device was returned with the inner member separated at the proximal balloon marker and the balloon separated from the outer member at the proximal seal.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: 8360578
• MDR Text Key: 136853849
• Report Number: 2024168-2019-01332
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1012448-15
• Device Lot Number: 60202G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2037-2039-2017
• Patient Sequence Number: 1