MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	10300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It was reported, during a procedure on (b)(6) 2018, 30 cm of the manufacture's device fractured off and was left inside the patient.The physician attempted to use the manufacturer's device to enter the posterior descending artery (pda) for a diagnostic procedure.The physician maneuvered manufacturer's wire back and forth and could not get the wire to advance.The physician was not able to successfully use ifr for diagnosis and removed the manufacturer's wire, guidewire and guiding catheter as a system.Under fluoroscopy the physician observed a portion of the manufacturer's wire remained in the patient.On (b)(6) 2018, the patient underwent a second procedure with another physician to attempt remove the wire fragment remaining in the rca (right coronary artery, proximal to the pda).The physician used a cloverleaf snare to entrap the proximal end of the jailed wire.When pulling the snare back the wire separated at the ostium.A portion of the wire was successfully removed and two stents were used to secure the remaining portion of the jailed wire in the in the mid and proximal rca.Ivus was used to confirm successful treatment and securement of the wire and the case ended.The patient was released from the hospital in stable condition.No tests/laboratory data was available.The implant or explant dates are not applicable to this device.As of this date the device has not been returned to the manufacturer for evaluation.Per the ifu: warnings: never advance, torque or retract a pressure guide wire which meets significant resistance.Precautions: do not use product that has been damaged in any way as this may result in vessel damage, inaccurate pressure measurements and/or poor torque response.The pressure guide wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Any time that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance.In some instances, the wire may kink and must be removed.The manufacturing documentation for this device was reviewed and the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 that during a coronary diagnostic procedure the manufacturer's device separated in the posterior descending artery (pda).This event is being reported because of device separation, additional intervention and patient hospitalization.
Additional Manufacturer Narrative
Internal reference: (b)(4).The device was returned and evaluated according to the manufacturer's policy.Visual and microscopic inspection was performed on the returned portions of the device.The wire was returned with a third party snare.The wire was returned in four (4) pieces.The broken hypotube was observed to be slightly curved and tapered.Two wire pieces were returned wrapped around the third party snare.Approximately 175cm was separated from and not returned with manufactures device.The probable cause of the reported damage was mechanical strain, as evidenced by the fracture ends of the wire pieces being tapered or curved.However, we were unable to conclusively determine how the damage to the device occurred.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.This supplemental report (#1) is being submitted because the device was received and analyzed by the manufacturer.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.This supplemental report (#2) is being submitted to correct an entry error in the device analysis provided in supplemental report #1.
Additional Manufacturer Narrative
Internal reference: (b)(4).During an internal review on 20 july 2018 it was observed an entry error was made in the device analysis and findings provided in the supplemental (#1) mdr.This report corrects the entry error.There are no other changes to the information reported or the conclusions provided in the initial or supplemental (#1) report.Device analysis was updated on 20 july 2018 correcting that 88.6cm of the device was not returned for analysis.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 7481661
• Report Number: 2939520-2018-00029
• Device Sequence Number: 1339680
• Product Code: DQX
• UDI-Device Identifier: 00845225002459
• UDI-Public: (01)00845225002459(17)190531
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131288
• 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,Followup,Followup
• Report Date (Section B): 04/25/2018

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: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: 10300
• Device Catalogue Number: 400-0300.14
• Device Lot Number: 0245 50064492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 07/20/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 05/24/2018; 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: Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 126