MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN TREK; DILATATION CATHETER

Catalog Number UNK NC TREK

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Estimated date of event.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot 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 deflation issue since the device was not returned for analysis and limited information was provided.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that an unk nc trek balloon would not deflate entirely within the stent.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: UNKNOWN TREK
• 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: 10083462
• MDR Text Key: 193359133
• Report Number: 2024168-2020-04473
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

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 Catalogue Number: UNK NC TREK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/22/2020
• 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