MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN DILATATION CATHETER

Catalog Number UNK NC TREK

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Estimated date of event.Unique device identifier (udi): the udi is not available because the part number and lot number were not provided.Exemption number e2019001.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported failure to fold; however, factors that could contribute to failure to fold include, but are not limited to, inadequate time allowed for balloon deflation and balloon material.The reported failure to advance and difficulty to remove appear to be related to operational context of the procedure as it is likely the reported incomplete balloon refold interacted with the lesion causing the reported failure to advance.The device interacted with the guiding catheter during removal causing the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the 2.0mm nc trek balloon dilatation catheters failed to pass the same or other coronary lesion due to incomplete refolding.Additionally, difficulty removing the balloon dilatation catheter has been felt when attempting to go through the guiding catheter.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: UNKNOWN DILATATION CATHETER
• Type of Device: 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: 9341443
• MDR Text Key: 177666757
• Report Number: 2024168-2019-13726
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK NC TREK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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