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

Model Number	1012280-15
Medical Device Problem Codes	Deflation Problem (1149); Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the pulmonary artery.After two inflations at 6 atmospheres, the balloon only partially deflated.During retrieval, resistance was met with the anatomy.Force was applied and the device separated at the proximal end of the balloon.The distal portion was retrieved with biopsy forceps.There was a 40-minute delay in the procedure.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu), states: if resistance is felt, determine the cause before proceeding.The ifu also states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.It is unknown if the reported ifu violation caused or contributed to the reported complaint.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 was unable to determine a conclusive cause for the reported deflation issue.The reported separation appears to be related to operational context/ 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
Additional information received: the separation occurred on the shaft not the balloon.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: 9786424
• Report Number: 2024168-2020-01986
• Device Sequence Number: 19424742
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 91018G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: Required Intervention