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

Model Number 1012455-20

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation has not yet been completed.A follow up report will be submitted with all additional relevant information.(b)(4).

Event Description

It was reported that this was a procedure to treat a lesion with heavy calcification and moderate tortuosity in the superior mesenteric artery (sma).The lesion was pre-dilated, and a 4.0 x 38 mm xience sierra stent was implanted successfully.Intravascular ultrasound (ivus) was performed and the stent was well apposed.A 5.0 x 20 mm nc trek balloon catheter was advanced for post dilation.However, at the third inflation at 16 atmospheres the balloon ruptured.During removal of the balloon catheter, the distal shaft separated in two pieces inside the guiding catheter as there was resistance between the devices.A snare device was used to securely with withdrawal the separated distal shaft.The patient remained stable.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported balloon rupture was not confirmed; however, the noted tear in the outer member distal to the outer member to hypotube seal is likely what the account perceived as the reported balloon rupture.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device and balloon rupture; however, the reported separation and additional treatment appear to be related to operational context.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: 9824064
• MDR Text Key: 185907276
• Report Number: 2024168-2020-02319
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Device Lot Number: 00109G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4X38MM XIENCE SIERRA STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 46