MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX; CORONARY DILATATION CATHETER

Catalog Number 1012451-12

Device Problems Deflation Problem (1149); Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for evaluation.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 inflation and deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that prior to use in the patient, the 3.50x12 mm nc trek balloon dilatation catheter (bdc) was prepped outside the patient.Upon air aspiration, balloon completely did not inflate.Staff tried to inflate/deflate by putting air; however, failed to inflate or deflate.Inflation was attempted 3 times under nominal pressure and negative pressure was held 3-5 seconds to deflate.The device was not used and there was no patient involvement.A new, same size nc trek bdc was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001 permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Device code 1149 was removed and code 1354 was added.

Event Description

Additional reported information received 11/14/2019 indicates that the during preparation of the device, the air could not be aspirated and the balloon would not inflate.There was no deflation issue as initially reported.No additional information was provided.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9330800
• MDR Text Key: 177238713
• Report Number: 2024168-2019-13634
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 1012451-12
• Device Lot Number: 90813G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1