MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012280-12
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 incidents from this lot.It is possible that interaction with the guide liner and/or other devices resulted in compromising the inflation/deflation lumen thus resulting in the reported deflation problem and difficult to remove; however this cannot be confirmed.Manipulation of the device in attempts to remove resulted in the reported material separation.As reported, all parts of the separated device were removed, except for the balloon portion with the markers.The separated inflated balloon with markers was left in the aneurysm that was going to be occluded.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during an aneurysm repair procedure, the trek rx was advanced and inflated.A guide liner was advanced over the balloon.Attempts were made to deflate the balloon, but it failed to deflate.Some trouble shooting was performed, but the balloon still could not be deflated.During removal of the inflated balloon, it was pulled into the guide catheter, but broke mid-shaft.The separated portion was snared and pulled into the guide catheter, but the shaft broke again.All parts of the separated device were removed, except for the balloon portion with the markers.After a surgical consult the separated inflated balloon with markers was left in the aneurysm that was going to be occluded.The patient remained stable and remained hospitalized for another day for monitoring.No additional information was provided.

• Brand Name: 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: 10627330
• Report Number: 2024168-2020-08254
• Device Sequence Number: 3054537
• Product Code: LOX
• UDI-Device Identifier: 08717648138775
• UDI-Public: 08717648138775
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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
• Report Date (Section B): 10/05/2020

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: 09/30/2022
• Device Model Number: 1012280-12
• Device Catalogue Number: 1012280-12
• Device Lot Number: 91018G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/05/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70