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

Model Number 1012453-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that after inflating the 4x15mm nc trek balloon once in the procedure, withdrawal of the device was attempted, but resistance was noted.At that point it was noted that the balloon did not fully deflate and could not be pulled into the guiding catheter.Inflation and deflation were performed several times at a low pressure; however, the balloon would not completely deflate.The balloon catheter and guiding catheter were removed together.There was no adverse patient effect or a clinically significant delay in the procedure.A new guiding catheter was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deflation problem was unable to be replicated in a testing environment as the returned device had a pinhole rupture on the balloon.Additionally, it was noted that the inner and outer member was stretched and the hypotube was separated.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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy/other devices and/or an insufficient time was not allowed to deflate the balloon before an attempt was made to remove the device resulting in the noted stretched inner and outer member; thereby, reducing the inflation/deflation lumen; thus resulting in the reported deflation problem.Manipulation of the device during removal resulted in the noted multiple device damages (separated hypotube/hub, pinhole rupture).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the balloon was inflated 2-3 times at 1-2 atmospheres.No additional information was provided.

Event Description

Subsequent to follow-up#1 medwatch report, the following information was provided: it was reported that the procedure was to treat an unknown lesion.The physician inflated the 4.0x15mm nc trek balloon dilatation catheter (bdc) once at nominal pressure.During retraction, resistance was met and the bdc could not be drawn into the guiding catheter as it was noted the balloon was not completely deflated.The balloon was inflated two to three times at 1-2 atmospheres (atm) in an attempt to deflate the balloon completely; however, the balloon ruptured and the shaft separated.The whole system was removed, and a new guiding catheter was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deflation problem was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.The reported material rupture and material separation were able to be confirmed.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy/other devices and/or an insufficient time was not allowed to deflate the balloon before an attempt was made to remove the device resulting in the multiple noted stretched inner and outer member thereby reducing the inflation/deflation lumen; thus resulting in the reported deflation problem and the reported difficult to remove.Manipulation of the device during removal resulted in the reported multiple device damages (separated hypotube/hub, pinhole rupture).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): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9946826
• MDR Text Key: 187179851
• Report Number: 2024168-2020-03563
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 90703G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1