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

Model Number	1012451-08
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified and moderately tortuous lesion in the left anterior descending artery.An nc trek 3.50x8mm balloon dilatation catheter (bdc) was used in the anatomy, but the physician noted that the balloon failed to deflate on the initial attempt.After multiple attempts, the balloon successfully deflated and was removed from the anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: after the balloon was used, it completely failed to deflate.The physician held negative for quite a while with the endoflator with no success.The decision was then made to switched out to a syringe.After making multiple attempts to deflate, it finally worked.No additional information was provided.
Additional 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 deflation issue.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B1: adverse event.B2: required intervention.B5: subsequent information.H1: serious injury.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9793955
• Report Number: 2024168-2020-02044
• Device Sequence Number: 2533569
• Product Code: LOX
• UDI-Device Identifier: 08717648151965
• UDI-Public: 08717648151965
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 1012451-08
• Device Catalogue Number: 1012451-08
• Device Lot Number: 90416G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention