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

Catalog Number 1012406-20

Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a percutaneous coronary intervention was performed in the distal right coronary artery (rca), thrombotic lesion.Prior to trek dilatation catheter insertion, the flush port un-twisted from the syringe portion of the treks hub.Reportedly, the syringe was difficult to connect to the trek's hub as it would untwist from the syringe.The same trek device was used, and the flush port held as the rca lesion was dilated up to 14 atms without further issues.Following, the trek was difficult to remove from the balance middle weight (bmw) guide wire as it was reportedly tight.The trek was removed and the procedure was completed with the same bmw guide wire without further issues.Stents were implanted without further issues.There were no adverse patient effects reported.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for evaluation.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 by the account that although difficulty connecting the syringe and balloon dilatation catheter (bdc) was experienced, the device was still used to complete the procedure.It should be noted that the coronary dilatation catheters instruction for use states: prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 8532159
• MDR Text Key: 142513470
• Report Number: 2024168-2019-03113
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1012406-20
• Device Lot Number: 80306G1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 04/19/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCE MIDDLE WEIGHT GUIDE WIRE; BALANCE MIDDLE WEIGHT GUIDE WIRE
• Patient Age: 74 YR
• Patient Weight: 73