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

Model Number	1012447-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 the moderately calcified, mildly tortuous mid left circumflex coronary artery.The 2.5x15 mm nc trek balloon dilatation catheter (bdc) ruptured when inflated twice to 14 atmospheres (atm).There was no resistance during advancement and the device was prepped per the instructions for use.A non-abbott bdc was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported balloon rupture was not confirmed; however, it is likely that the noted tear on the outer member distal to the mid lap seal is what the account perceived as the reported rupture since the device would not hold pressure during second inflation.A review of the lot history record revealed one manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined a potential product quality issue based on the elhr exception review and the noted tear on the outer member distal to the mid lap seal during return analysis.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
It was reported that the procedure was to treat the moderately calcified, mildly tortuous mid left circumflex coronary artery.The 2.5x15 mm nc trek balloon dilatation catheter (bdc) ruptured when inflated twice to 14 atmospheres (atm).There was no resistance during advancement and the device was prepped per the instructions for use.A non-abbott bdc was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to the initially filed report the following information was provided: reportedly, the balloon was only inflated once to 14 atm.A second attempt may have been made but the account does not recall the information.No additional information was provided.

• 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: 14337625
• Report Number: 2024168-2022-05006
• Device Sequence Number: 5221503
• Product Code: LOX
• UDI-Device Identifier: 08717648151767
• UDI-Public: 08717648151767
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/13/2022

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: 12/31/2024
• Device Model Number: 1012447-15
• Device Catalogue Number: 1012447-15
• Device Lot Number: 20117G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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