MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX; CORONARY DILATATION CATHETER

Model Number	1012276-30
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Syncope (1610); Perforation (2001)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the reported information, the trek balloon dilatation catheter was inflated once at 16 atmospheres (above rbp), and a perforation was noted after its use.It should be noted that the ifu, cdc, trek rx and mini trek rx, global, instructions for use states: balloon pressure should not exceed the rated burst pressure (rbp).The investigation determined the reported difficulties appear to be related to user error.It is likely that during the inflation of the balloon above rbp, the balloon likely damaged the vessel.A conclusive cause for the reported patient effect of syncope and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the 100% stenosed mid right coronary artery.A 3.5x30mm trek balloon dilatation catheter was inflated once at 16 atmospheres, and a perforation was noted after its use.Four non-abbott covered stents were used as treatment, and the patient was discharged on (b)(6)2020.The patient returned on (b)(6) 2020 with syncope, but there was no treatment.The patient was discharged on (b)(6) 2020 and the patient is in good condition.There was a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10159815
• Report Number: 2024168-2020-05081
• Device Sequence Number: 19700057
• Product Code: LOX
• UDI-Device Identifier: 08717648138607
• UDI-Public: 08717648138607
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 06/16/2020

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: 1012276-30
• Device Catalogue Number: 1012276-30
• Device Lot Number: 91029G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/16/2020
• 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: 79 YR
• Patient Weight: 71