MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .014 PLATINUM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	400-0200.233
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.By report, this was a diagnostic peripheral procedure.Images were obtained by the manufactures catheter device prior to removal.Resistance was experienced when the wire (another manufacturer's device) and manufacturer's catheter device were being removed.Additional surgical intervention was able to remove part of the catheter device.When the manufacturer's device was removed it was found to be kinked and tangled in the wire.No tests/laboratory data was available.Entangled wire.Make and model unknown.The implant or explant dates are not applicable to this device.Device was discarded and not returned for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.Additionally, complaints are monitored by monthly complaint review board process.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported the manufacturer's device was stuck in the patient's body.The user was unable to pull out the manufacturer's device and ultimately surgical removal was done.Patient recovered and was released.This mdr is being submitted because medical and surgical intervention was required to remove the catheter device.

• Brand Name: VISIONS PV .014 PLATINUM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7737880
• Report Number: 2939520-2018-00074
• Device Sequence Number: 1040191
• Product Code: OBJ
• UDI-Device Identifier: 00845225002428
• UDI-Public: (01)00845225002428(17)180930
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143701
• 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): 07/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 400-0200.233
• Device Catalogue Number: 0242 50077875 118
• Device Lot Number: 85910P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/31/2018
• 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