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

Catalog Number 1012276-30

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problems Occlusion (1984); Foreign Body In Patient (2687)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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 procedure was to treat a restenosis in the mid right coronary artery.The patient presented with cardiogenic shock and intravascular ultrasound (ivus) was performed.Dilatation was done with a 3.5 x 30 mm trek balloon catheter, which was inflated once above the rated burst pressure at 16 atmospheres for 20 seconds.The device did not meet any resistance during advancement.It could not be confirmed whether there was a balloon rupture; however, when the device was removed, it was noted that the balloon had detached from the device.The vessel was occluded; therefore, an unspecified guide wire was advanced, dilatation was performed and a 3.5 x 33 mm xience prox stent was implanted.However, the trek balloon could not be retrieved nor found so the patient was transferred to the intensive care unit.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned device.The reported separation was confirmed.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 of the reported lot did not indicate a lot specific quality issue.It should be noted coronary dilatation catheters, trek rx instruction for use(ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).Also the ifu states, the reported patient effect of occlusion, is a known patient effect that may be associated with use of a coronary catheter in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported separation; however, the reported patient effects of occlusion and foreign body in patient 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 this 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
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7014531
• MDR Text Key: 91514181
• Report Number: 2024168-2017-08837
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1012276-30
• Device Lot Number: 70519G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention