MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Catalog Number 1012274-20

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide catheter: boston scientific 6f cl3.5; dilatation catheter: 3.0 x 20 mm trek; stent: 2.5 x 8 mm xience sierra.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional trek rx and xience sierra devices referenced are being filed under separate medwatch reports.

Event Description

It was reported that the procedure was to treat a moderately tortuous, bifurcation lesion in the diagonal and mid left anterior descending (lad) artery with 80% stenosis.The 2.5 x 8 mm xience sierra drug eluting stent was deployed in the lad.Plaque shift occurred closing off the diagonal artery during stent deployment.Kissing balloon technique was performed for post dilatation with two 3.0 x 20 mm trek balloon dilatation catheters (bdc) to open the stent struts of the xience and improve the blood flow in the diagonal.The first 3.0 x 20 trek was advanced to the lad and the second 3.0 x 20 trek was placed in the diagonal artery.Resistance had been met with the guiding catheter during advancement of both treks.Both balloons were inflated to 12 atmospheres and negative pressure was held 4 seconds to deflate the balloons.During removal of the second trek bdc, strong resistance was met as the balloon was only partially deflated.Force was used to remove the bdc and the shaft separated.The decision was made to inflate the other trek balloon to assist in removing the separated trek shaft, but resistance with the guide catheter was also met with this trek.All the devices were removed as a unit.A new guide catheter and balloon catheters were used to complete the procedure.The outcome was not as good as they had hoped because the diagonal vessel became occluded, but the patient is doing well.No additional information was provided.

Manufacturer Narrative

(b)(4).The unknown abbott guide wire referenced is filed under separate medwatch manufacturer report number.Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported shaft separation was confirmed.The reported difficulty removing the guide wire from the device could not be confirmed.The reported difficulty removing the device from the guiding catheter, deflation issue and difficulty positioning the guiding catheter 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 incidents from this lot.It was reported that force was used to remove the bdc and the shaft separated.It should be noted coronary dilatation catheters, trek rx, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, since the balloon failed to deflate and strong resistance was encountered, the reported force was a typical clinical response given the situation.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, the separation, difficulty removing the guide wire from the device, difficulty removing the device form the guiding catheter, difficulty positioning the device in the guiding catheter appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial medwatch report filed, a damaged abbott guide wire was returned to abbott vascular.Follow-up with the account confirmed the this guide wire was used with the 3.0x20 mm trek balloon.There was difficulty removing the trek from the abbott guide wire, so all devices were removed as a unit.The patient is doing well.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7507802
• MDR Text Key: 108035835
• Report Number: 2024168-2018-03500
• Device Sequence Number: 1
• Product Code: LOX
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• 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: 80130G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ABBOTT GUIDE WIRE
• Patient Outcome(s): Required Intervention