MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE PLATINUM ST CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900PST

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempts to obtain patient information was unsuccessful.Attempts to obtain the patient information were made via email and phone.The implant or explant dates are not applicable to this device.The returned device was visually and microscopically inspected.The device was returned stuck within an angiographic catheter.A 114 mm section of the proximal shaft and core wire were cut with the microcables missing; a 101 mm section consisting of the a portion of the proximal shaft, the luer, and connector cable were cut; the distal shaft was torn 31 mm from the distal tip.The core wire was protruding from the device 46 mm from the proximal end of the distal portion of the device.The proximal fillet was lifted, but intact with no portions missing.There were several striations around and along the distal shaft and scanner.The probable cause of the reported movement failure is damage during pullback as evidenced by the puncture on the distal shaft and lifted proximal fillet.The puncture is the likely result of the device being pulled against the guidewire while the device was stuck.Strain, impact, and forces associated with use can affect the integrity of the device.There was no damage observed on the device that could contribute to the reported failure.It could not be conclusively determined when the cause of the failure occurred.The customer stated that the core wire was exposed following intervention.The probable cause of the exposed core wire is user induced damage during intervention as evidenced by the cuts on the device.As the core wire is anchored within the luer, intentionally severing the device distal to the luer may result in core wire becoming unstable within the device.The instructions for use (ifu) cautions if resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.Do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.

Event Description

It was reported the catheter was used for an evt ppi (endovascular therapy / percutaneous peripheral intervention) for an inferior limb.There was no stent placed.During pullback inside the body the catheter was stuck.The shaft was cutting [cut] and an angiographic catheter was inserted to remove the manufacturer's catheter.After removing the catheter from the body, the user found the core wire was exposed.No damage was observed during prep.Treatment was completed by the procedure.There was no patient injury.Calcification: moderate.This event is being reported because additional intervention was required to remove the device.

• Brand Name: EAGLE EYE PLATINUM ST CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; b37; alajuela, ; CS
• Manufacturer Contact: tom brennan ; 3721 valley centre dr ste 500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6734034
• MDR Text Key: 80750415
• Report Number: 2939520-2017-00069
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(17)190531
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120697
• 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: 06/21/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0231 50100659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• 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
• Patient Outcome(s): Required Intervention