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

Model Number 1012455-15

Device Problems Entrapment of Device (1212); Failure to Deflate (4060)

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

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with mild calcification.An unspecified skypoint stent was implanted to treat the target lesion.Then a 5.00 x 15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and was successfully used for post dilatation; however, the balloon failed to deflate causing a clinically significant delay in the procedure.The bdc was unable to be removed from the patient; therefore the physician had to puncture the balloon with a rigid wire and the bdc was removed from patient.An unspecified balloon was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported failure to deflate and entrapment of device or device component.The reported unexpected medical intervention and delay to treatment/therapy 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 the device.

• Brand Name: NC 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: 13742248
• MDR Text Key: 287538344
• Report Number: 2024168-2022-02556
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2022

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: 04/30/2024
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 10531G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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
• Treatment: 1 IMPLANTED SKYPOINTE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic