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

Catalog Number 1012272-20

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

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) above rated burst pressure.The device is expected to be returned for evaluation.It has not yet been received.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 lesion in the mid left anterior descending coronary artery with 70% stenosis.A 2.50 x 20 mm trek rx balloon dilatation catheter (bdc) was advanced to the lesion with resistance.The balloon of the bdc was inflated 5 times to 20 atmospheres.While there was no reported problems with deflation of the balloon, the balloon failed to rewrap and the bdc met resistance of an unknown cause on removal.The balloon had to be repeatedly pressurized and depressurized up to 20 atmospheres in an attempt to rupture the balloon.The bdc was ultimately withdrawn with the balloon deflated.The procedure was successfully completed with a new 2.50 x 20 mm trek rx.There was no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: a visual inspection was performed, and the reported winged balloon was confirmed.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Reportedly, the balloon was inflated 5 times to 20 atmospheres, which is above rated burst pressure (rbp).It should be noted that the trek rx instructions for use states: balloon pressure should not exceed the rbp.Use of a pressure-monitoring device is recommended to prevent over-pressurization.In this case, the device/balloon being pressurized above rbp does not appear to contribute to the reported issues.The investigation determines the reported difficulties appear to be related to circumstances of the procedure.It is likely that the balloon was not fully deflated during retraction causing resistance and the difficulty to remove which resulted in the inner member damage and the balloon to refolding flat.There is no indication of a product quality issue with respect to 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: 8179602
• MDR Text Key: 131215700
• Report Number: 2024168-2018-09861
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

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: 01/31/2021
• Device Catalogue Number: 1012272-20
• Device Lot Number: 80209G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1