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

Model Number	1012445-12
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
2017 code clarifier - above rated burst pressure.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 performed to treat a mildly tortuous and heavily calcified lesion in the distal left main into the left anterior descending coronary artery.A 2.0x12mm nc trek balloon dilatation catheter (bdc) was prepared per the instructions for use.The bdc was advanced to the lesion; however, ruptured during the first inflation at 19 atmospheres.The procedure was successfully completed with an unspecified balloon catheter and the deployment of an unspecified stent.There were no adverse patient effects and no clinically significant delay in the procedure.User facility medwatch report received that states: according to the reporting, this elderly male was undergoing a percutaneous transluminal coronary angioplasty (ptca) for stenting of the left main and left anterior descending (lad) artery.Patient previously had coronary artery bypass graft (cabg) x3, following standard insertion of the nc trek rx balloon into the left main artery during inflation of the balloon at 19 atms for 43 seconds the balloon was noted to rupture.The device was removed without incident and inspected.The balloon was deemed to be intact by the physician and the cath lab staff.The balloon was tagged and retained by the hospital.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual inspection was performed on the returned device.The balloon rupture was confirmed.It should be noted that the coronary dilatation catheters nc trek rx global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atmospheres.In this case, it is likely the combination of the ifu deviation and the mildly tortuous and heavily calcified anatomy resulted in the reported balloon rupture.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 determined the reported balloon rupture appear to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• 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
• MDR Report Key: 8931842
• Report Number: 2024168-2019-11167
• Device Sequence Number: 242325
• Product Code: LOX
• UDI-Device Identifier: 08717648151644
• UDI-Public: 08717648151644
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/20/2020

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: 02/28/2022
• Device Model Number: 1012445-12
• Device Catalogue Number: 1012445-12
• Device Lot Number: 90314G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 07/20/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 11/14/2019; 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 94