MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).Facility declined to provide patient information.The implant or explant dates are not applicable to this device.Concomitant medical products: microcatheter: caravel; asahi intec, balloon catheter: ryusei;terumo.State/prefecture is (b)(6).The device was discarded at the customer site and will not be returned for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
It was reported during a diagnostic coronary ifr procedure the manufacturer's device was advanced to distal lad (left anterior descending artery) when the tip went into septal branch unexpectedly, got stuck and could not be removed by itself.They exchanged from 5fr.System to 6fr.And a microcatheter was inserted over the device, advanced beyond the tip and the manufacturer's device was removed.Effusion and a perforation were observed under angiogram, a balloon catheter was inflated and placed for 10 minutes.They confirmed the balloon worked with no effusion.The procedure was finished without ifr measurement.A pci procedure is scheduled for this patient at a later date.Vessel: highly tortuous and severely calcified lesion with 75% stenotic lesion was at #7, lad.This adverse event is being submitted because additional intervention was required to remove the manufacturer's device.Additionally, the patient's vessel was perforated (with effusion) requiring additional intervention.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 9630538
• Report Number: 2939520-2020-00002
• Device Sequence Number: 16580001
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)220930(10)0301744831(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K161887
• 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): 01/10/2020
• Report Date (Section F): 01/01/2005

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: 09/30/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301744831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/26/2020
• 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: 85 YR
• Date Report Sent to FDA: 01/01/2005