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

Catalog Number 1012274-12

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problems Intimal Dissection (1333); Angina (1710)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during device preparation, the protective sheath was difficult to remove.During the procedure, the 3.0x12 mm trek rx balloon catheter was advanced to the ostial circumflex target lesion and inflated, but it was difficult to see the inflated balloon.The contrast mix was changed out but that did not help the visualization.Different views were used to visualize the trek, but the distal end of the balloon appeared smaller than the proximal end.It looked like a napkin ring 2 mm before the distal marker.The trek was inflated four times between 6 and 8 atmospheres for 15 to 20 seconds with each inflation.When deflating the balloon, only the distal end was able to deflate.The proximal half of the balloon would not deflate and after three minutes, the patient began to experience chest pain.The partially deflated trek was pulled into the guide catheter, but met resistance with the guide catheter.During this, the guide catheter went forward and was thought to have dissected the left anterior descending coronary artery.After the trek was removed the physician wanted to treat the lad.A guide wire was inserted but was unable to advance more than 10 mm through the lad.Although the chest pain resolved with removal of the trek and the vital signs were stable, the patient was sent to surgery as the physician did not like how the lad looked on the film.The patient is doing great after the surgery.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and dimensional inspections were performed on the returned device.The reported inflation and deflation issues and difficulty removing the protective sheath could not be replicated in a testing environment due to the condition of the returned device.The reported visibility issue and difficulty removing the device could not 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 other incidents from this lot.The reported patient effects of dissection and angina as listed in the coronary dilatation catheters (cdc), trek rx global instructions for use are known patient effects.The investigation was unable to determine a conclusive cause for the reported inflation, deflation issues and difficulty removing the protective sheath; however, the reported difficulty visualizing the device, difficulty removing the device from the guiding catheter and patient effects of intimal dissection and angina appear to be related to operational context.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
• 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: 6796431
• MDR Text Key: 82752165
• Report Number: 2024168-2017-06717
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

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: 03/31/2020
• Device Catalogue Number: 1012274-12
• Device Lot Number: 70426G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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): Hospitalization; Required Intervention