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

Model Number	1012451-20
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported by the account that the balloon was inflated up to 22 atmospheres (atms) and subsequent angiography revealed a moderate-sized contained vessel injury.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).In this case, it is unknown if the ifu violation contributed to the reported perforation.The reported patient effect of perforation is listed in the coronary dilatation catheters (cdc), nc trek rx, global, ifu as a known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined; however, the reported ifu violation (above rated burst pressure]) appears to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that percutaneous coronary intervention was performed in the mid left anterior descending coronary artery.Aspiration thrombectomy was performed and three overlapping stents were implanted using non-abbott stents.Post dilatation was performed with the 3.5x20 nc trek inflated to 22 atmospheres.Subsequent angiography revealed a moderate-sized contained vessel injury.Prolonged balloon inflation was performed for approximately twenty minutes, but there continued to be communication to the contained space.There was no significant pericardial effusion.The 2.8x16 mm graftmaster stent was implanted at 22 atmospheres to treat the perforation and it successfully sealed it.The condition resolved.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
• MDR Report Key: 11995891
• Report Number: 2024168-2021-04955
• Device Sequence Number: 922887
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 10127G3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/14/2021
• 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
• Patient Age: 67 YR
• Patient Weight: 62