MAUDE Adverse Event Report: VOLCANO CORPORATION REVOLUTION 45MHZ IVUS IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89000
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempts to obtain patient information was unsuccessful as the facility declined to provide the information.Additional information obtained indicated no damage was observed during prep.Resistance was felt.All portions of the device appeared accounted for after removal from the patient.Catheter device was removed as a system.Treatment was completed by the procedure.The implant or explant dates are not applicable to this device.The returned device was received in three pieces with the guide wire still attached.The inner telescope was broken near the telescope proximal strain relief.The proximal shaft was also broken at 98mm distal to the distal telescope strain relief.There was indentation near the proximal end break of the shaft and the guidewire was stuck at this location.The shaft was flattened at the distal and proximal end breaks, indicating that the shaft was kinked prior to the separation.Device manipulation, impact and applied pressure associated with use can affect the integrity of the device.Unfortunately, we could not conclusively determine when or how the damage occurred the instructions for use (ifu) warns, do not advance the catheter if resistance is encountered.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.The ifu cautions the device is a delicate scientific instrument and should be treated as such.The ifu contraindicates use in vessels with severe arterial calcification.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 or Problem Description
It was reported during a coronary therapeutic procedure that during insertion prior to cross[ing] the severely calcified lesion inside the body the catheter was trapped and could not be moved back.The inner catheter (drive cable, etc.) was removed from the connector and a gw (guide wire) was inserted into the outer catheter from the connector.The gw and the catheter were removed together as a system from the body.There was no patient injury.Vessel: #7 / calcification: severe.This event is being reported because additional intervention was required to remove the catheter device.

• Brand Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7089479
• Report Number: 2939520-2017-00088
• Device Sequence Number: 16551522
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)180630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080891
• 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
• Report Date (Section B): 11/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 89000
• Device Catalogue Number: 8505000001
• Device Lot Number: 0035 50104904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• 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