MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Model Number	518-037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable from facility.Physician information unavailable from facility.
Event or Problem Description
It was reported by a philips representative on (b)(6) 2020 that an event occurred on (b)(6) 2020 in which a spectranetics quick-cross support catheter was being used.It was reported on (b)(6) 2020 by the facility that the procedure was a left lower extremity angiogram and balloon angioplasty.It was reported that the distal segment of the quick-cross catheter had broken off in the patient's left iliac artery.It was reported that there was an attempt to retrieve the device portion; however the surgeon reported that this quick-cross distal segment of catheter was left in place within the patient.The patient reportedly survived the procedure.No further information is available from the facility, although it has been requested.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10785876
• Report Number: 1721279-2020-00218
• Device Sequence Number: 2909413
• Product Code: DQY
• UDI-Device Identifier: 00813132020682
• UDI-Public: (01)00813132020682(17)220529(10)FQQ20E29A
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K033678
• 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): 10/06/2020

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: 05/29/2022
• Device Model Number: 518-037
• Device Catalogue Number: 518-037
• Device Lot Number: FQQ20E29A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• 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: 74 YR
• Patient Weight: 61