MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	81234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional information provided the patient underwent two separate planned interventions within the same procedure and experienced two separate adverse events.This submission is for the diagnostic venous arteriogram portion of the procedure.Further information provided the device performed as intended and successful imaging was obtained.Upon removal from the patient's vasculature the tip of the device was observed to be missing.It was decided to leave the tip in place and proceed with the 2nd scheduled procedure of a diagnostic arterial fistulagram.No attempts were made to retrieve the tip as its location could not be identified under fluoroscopy.The second portion of the procedure, the diagnostic arterial fistulagram, is reported under mdr 2939520-2018-00119.Relevant test/lab data: no tests/laboratory data available.Other relevant history: no information available.Implant and explant dates: the implant or explant dates are not applicable to this device.Concomitant product(s): no information available.Visual and microscopic inspection were performed on the returned device.Approximately 12 mm of the catheter tip was separated and not returned with the device.All other portions of the device were accounted for.The probable cause of the tip separation is damage in use.Per the ifu, if resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath guide catheter) at the same time.Strain, impact, and forces associated with use can affect the integrity of the device.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported during a diagnostic peripheral procedure, the end of the manufacturer's device broke off in the patient.No other devices were used to complete the procedure.This adverse event is being reported because the tip of the manufacturer's device separated and remains in the patient.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7932723
• Report Number: 2939520-2018-00118
• Device Sequence Number: 1449503
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(17)200731(10)0301481405(90)989609000971
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• 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): 09/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0301481405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 10/03/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 131