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

Model Number 1012268-06U

Device Problems Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2020

Event Type  Injury  

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 Description

It was reported the procedure was to treat a lesion in the left main (lm) artery.The 1.20x6mm rx mini trek balloon dilatation catheter (bdc) was advanced to the lesion and the balloon inflated three times to 20, 15, and 15 atmospheres (atm) respectively when the balloon ruptured.The device was removed however it was noted the shaft had separated, the distal 10cm of the device remained in the anatomy.Attempts to retrieve the separated portion were unsuccessful and the device remains in the anatomy.The patient was transferred to the intensive care unit (icu) to be further monitored.No additional information was provided.

Manufacturer Narrative

The device was returned.Visual inspection was performed on the returned device.The reported separation was confirmed.The reported balloon rupture could not be determined since the balloon was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents/complaints from this lot.It should be noted that the coronary dilatation catheters (cdc), mini trek instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the mini trek device is 14 atm; therefore, rbp was exceeded.The investigation determined the reported balloon rupture appears to be related to user error as it was reported by the account that 1.20 x 6mm rx mini trek bdc was advanced to the lesion and the balloon inflated three times to 20, 15, and 15 atmospheres (atm) respectively when the balloon ruptured.The reported balloon separation, foreign body in patient, additional treatment and hospitalization appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9823562
• MDR Text Key: 184758712
• Report Number: 2024168-2020-02311
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648176531
• UDI-Public: 08717648176531
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1012268-06U
• Device Catalogue Number: 1012268-06U
• Device Lot Number: 90731G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention