MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE X, WIRELESS, RX 175CM; WIRE, GUIDE, CATHETER

Model Number C12059

Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Information from the field stated that the pressurewire was used with a 5f guiding catheter.The pressurewire instructions for use (ifu) ppl2119173 ver.A, directs the user to use the pressurewire guidewire in conjunction with a 6f (2 mm diameter) guiding catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturing ref: 3009564766-2020-00011.During the procedure, a delay occurred and the procedure took about 30-45 minutes longer.The devices were calibrated and equalized normally.5fr cag catheters were used along with the devices.The devices were attempted to be used for ffr measurement in a left circumflex artery lesion.When the first device was used, calcification in the lesion was severe and the device could not be passed through the lesion and the tip of the device bent limply.A second device was used but the same issue occurred.A delay occurred and the procedure took about 30-45 minutes longer.The procedure was completed without using a replacement with no adverse patient consequences.Additional information is not expected.

• Brand Name: PRESSUREWIRE X, WIRELESS, RX 175CM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 52 calle 3 b31 coyol free zone; alajuela 20102
• Manufacturer (Section G): ABBOTT VASCULAR; 52 calle 3 b31 coyol free zone; alajuela 20102
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10542877
• MDR Text Key: 207220766
• Report Number: 3009564766-2020-00010
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 05415067025715
• UDI-Public: 05415067025715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: C12059
• Device Catalogue Number: C12059
• Device Lot Number: 00504G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRESSUREWIRE¿ X, WIRELESS, RX 175CM
• Patient Outcome(s): Hospitalization