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

Model Number	10185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was discarded post-procedure and not returned for analysis.No physical product investigation was possible as the device was discarded at the facility.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.By report, prior to a diagnostic coronary procedure, when the device was removed from the inner sterile package, the guidewire was a j-tip and not a straight tip as the outer box label indicated.The physician opted to use the j-tip guidewire for the procedure.The procedure was completed successfully.There was no patient harm and the patient was discharged as expected.Vessel: mid lad roughly 60% stenosed, minimal tortuosity and calcification.The device was discarded post-procedure and not returned for analysis.The manufacturer confirmed the serial number reported as being on the outer package is for a straight tip guidewire.As the device was discarded, we were unable to confirm the serial number on the guidewire withdrawn from the package.The facility said they did not notice how the guidewire itself was labeled before it was discarded.The manufacturing documentation for the reported serial number 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.The subassemblies met the criteria for a straight tip guidewire.This complaint will be monitored as part of complaint data analysis.This event is being reported in an abundance of caution.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Further investigation results provided to this department on 09/01/2017 found that on the date of manufacture (04/25/2017) the four lots manufactured before, and the four lots manufactured after the affected lot were reviewed in the erp system.All of the devices are from model number 10185 straight tip with line clearances between each lot produced.The manufacturing process flow between straight tip and j tip is different, depending on part number / model number manufactured.The j tip shaping procedure is applicable when the 10185 j tip and 10300 j tip is being manufactured; this operation is not applicable for 10185 straight tip and 10300 straight tip.A check for rework activity was performed.There was no rework of lot 50098801 during the manufacturing process.There was no evidence that a j tip device was likely introduced into lot 50098801 during the manufacturing process.There was no indication of malfunction of the device nor of the manufacturing process.
Event or Problem Description
This follow-up report is being submitted as new information was obtained.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 6712856
• Report Number: 2939520-2017-00066
• Device Sequence Number: 197797
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)200430
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50098801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 120