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

Model Number	1012451-15
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Syncope/Fainting (4411)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional nc trek device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a chronic totally occluded lesion in an unspecified artery.The 3.5x8mm and 3.5x15mm nc trek balloon dilatation catheters (bdc) were inflated once up to 10 atmospheres (atms) and negative was held for 5 seconds to deflate the balloons, however, the balloons could not be deflated.There was no difficulty removing the stylet or protective sheath and the devices were prepared (air aspiration) outside the anatomy prior to use.Contrast mix used was per instructions for use.The devices were withdrawn fully inflated.The patient had no flow in the artery and hypotension occurred.Adenosine was administered intravenously and another balloon was used for post dilatation.Vasovagal sycope also occurred that needed time to treat and recover which caused a delay in the procedure.The patient improved and there was no prolonged hospitalization.No additional information was provided.
Additional Manufacturer Narrative
Date of event has been estimated.Visual and functional inspections were performed on the returned device.The reported failure to deflate could not be confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents/complaints from this lot.The reported patient effects of hypotension and occlusion are listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as known patient effects.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported patient effects of delay to treatment/therapy, unexpected medical intervention and medication required appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of hypotension, obstruction/occlusion and syncope/fainting and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 13315458
• Report Number: 2024168-2022-00724
• Device Sequence Number: 19999317
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 1012451-15
• Device Catalogue Number: 1012451-15
• Device Lot Number: 10610G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown