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

Model Number 1012455-08

Device Problem Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.The 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 a mildly calcified, mildly tortuous left anterior descending artery that was 90% stenosed.The lesion was pre-dilated with a 2.5mm non-abbott balloon.A 4.0x33mm xience sierra stent was deployed.After post-dilatation was performed with a 5.0x8mm nc trek balloon dilatation catheter at 18 atmospheres 2 times, the balloon could not be completely pulled back into the unspecified guiding catheter.The bdc and the guiding catheter were removed as a single unit.Hemostasis was performed on the puncture site (left radial).However, after the hemostasis, bleeding was noted again at the puncture site.It was not reported how the bleeding was resolved.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the device from the guiding catheter was confirmed.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 of the reported lot did not indicate a lot specific quality issue.The reported patient effect of hemorrhage is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as a known patient effect.The investigation determined the reported difficulty removing the device from the guiding catheter appears to be related to operational context.A conclusive cause for the reported patient effect of hemorrhage and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 9273826
• MDR Text Key: 165540719
• Report Number: 2024168-2019-13172
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 70321G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYPERION DPB3.5; SION BLUE; XIENCE SIERRA 4.0 X33
• Patient Outcome(s): Required Intervention