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

Catalog Number 1012455-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the 5.0x15mm nc trek balloon dilatation catheter (bdc) was used in a renal artery procedure.The balloon was inflated with no issue; however, during deflation, the balloon was unable to deflate completely and rewrap correctly and could not be removed.The balloon was re-inflated per the instructions for use (ifu), and the balloon deflated again; however the balloon would still not re-wrap enough and resistance was met during retraction; the balloon could not enter the sheath.Force was applied and the device was eventually pulled into the sheath and removed from the patient.Outside the patient, the physician inspected the balloon and stated the distal end of the balloon folds felt sharp.Although this issue caused a delay in the procedure, the delay did not result in adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: revised evaluation: visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was not confirmed.The reported difficulty removing the balloon dilatation catheter (bdc) from the introducer sheath was not confirmed.The reported folded (winged) balloon could not be replicated in a testing environment.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.The investigation was unable to determine a conclusive cause for the reported deflation issue or folded (winged) balloon; however, the reported difficulty removing the device from the introducer sheath appears to be related to circumstances of the procedure.It should be noted that the instructions 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, the reported violation of the ifu did not cause or contribute to the reported complaint.Additionally, the ifu states: the nc trek rx coronary dilatation catheter is 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 complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4).Correction: patient age.Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed.The reported difficulty removing the balloon dilatation catheter (bdc) from the introducer sheath and the folded (winged) balloon were confirmed.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.The investigation was unable to determine a conclusive cause for the reported deflation issue or folded (winged) balloon; however, the reported difficulty removing the device from the introducer sheath appears to be related to circumstances of the procedure.It should be noted that the 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.Additionally, the ifu states: the nc trek rx coronary dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis.In this case, the reported violations of the ifu did not cause or contribute to the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC 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: 7350108
• MDR Text Key: 102857212
• Report Number: 2024168-2018-01953
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• 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,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012455-15
• Device Lot Number: 70726G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2018
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR