MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

Catalog Number 1012268-12

Device Problems Inflation Problem (1310); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Visual, dimensional, and functional inspections were performed on the returned device, however, the reported inflation issues were unable to be 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 reported from this lot.Factors that may contribute to difficulty inflating or incomplete inflation of the device may include, but are not limited to, damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation/deflation technique, contrast dilution, inadequate connection to the inflation device, and/or accessory device support.Design and manufacturing controls have been established to mitigate possible causes.The investigation was unable to determine a conclusive cause for the reported inflation issues.In this case, it is possible that the moderately calcified and tortuous anatomy restricted contrast flow resulting in the incomplete inflation; however, this could not be confirmed.The noted damaged on the balloon catheter likely occurred during packing for returned analysis as there were no reports of damage to the balloon catheter.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the left circumflex artery that was both moderately calcified and tortuous.The mini trek balloon was used to post dilate a stent but only partially inflated.Another balloon was successfully used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified a tear at the guide wire exit notch.The contrast mix was per the instructions for use.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13052560
• MDR Text Key: 284983736
• Report Number: 2024168-2021-11950
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

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: 01/31/2022
• Device Catalogue Number: 1012268-12
• Device Lot Number: 90220G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 107 KG