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

Catalog Number 1012274-20

Device Problems Off-Label Use (1494); Material Separation (1562); Failure to Advance (2524)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Ischemia (1942)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.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 to treat a heavily calcified lesion distal to the popliteal artery and proximal to the anterior tibial artery.A non-abbott device was used to break up the calcified lesion.The 3.0 x 20 mm rx trek balloon dilatation catheter (bdc) was advanced however was unable to cross the lesion.The bdc was removed and replaced with another bdc however that device failed to cross and appeared to be stopping on something.The bdc was removed and it was noted under fluoro that the tip of the rx trek balloon had separated and remained in the anatomy.An attempt was made to snare the tip of the device however was unsuccessful.The procedure was aborted at this time.The patient was administered a tissue plasminogen activator (tpa) infusion to prevent any clotting due to the separated tip.The patient was kept in the hospital and over night, the patients foot began to change colors.The patient was brought back to the cath lab where the tpa infusion was discontinued.A balloon catheter was advanced and inflated several times to embedded the separated tip against the vessel wall with good results.The color returned to the patients foot and blood flow was increased.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.Visual inspection was performed on the returned device.The reported separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.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/complaints from this lot.It should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, information for use (ifu) states: the trek rx and mini trek rx coronary dilatation catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation determined the reported complaints and patient effects 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: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9083117
• MDR Text Key: 161217668
• Report Number: 2024168-2019-11875
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1012274-20
• Device Lot Number: 80131G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 65