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

Catalog Number	1012451-08
Medical Device Problem Codes	Deflation Problem (1149); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.The 3.5x8 mm nc trek balloon dilatation catheter (bdc) was inflated but could not be fully deflated.The balloon was withdrawn partially deflated.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.The 3.5x8 mm nc trek balloon dilatation catheter (bdc) was inflated but could not be fully deflated.The balloon was withdrawn partially deflated.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported that the device that failed to deflate was a non-abbott balloon.There was no issue with the nc trek bdc.There is no complaint against the nc trek bdc.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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.Based on the reported complaint there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device as it was reported that the complaint device was a non-abbott balloon.There was no issue with the nc trek bdc.There is no complaint against the nc trek bdc.Based on the additional information received, this event would not have been reportable.However since the initial mdr has already been filed, this event must remain reportable.D9/h3 - device available for evaluation updated from ¿yes¿ to ¿no.¿ d4 - medical device problem code 1149 was updated to 3189.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: 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: 18056841
• Report Number: 2024168-2023-12179
• Device Sequence Number: 6877283
• Product Code: LOX
• UDI-Device Identifier: 08717648151965
• UDI-Public: 08717648151965
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 1012451-08
• Device Lot Number: 30118G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown