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

Model Number	518-036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information unavailable from facility, although multiple requests were made.If further information is obtained, and/or the device is returned to the manufacturer for evaluation, a supplemental mdr will follow containing the additional information.
Event or Problem Description
A philips representative reported that a peripheral vascular procedure commenced and physician was reportedly using a spectranetics quick-cross support catheter to treat the patient.The representative was not present during the procedure.It was reported that during the procedure, the device's tip reportedly broke off.It was also reported that the patient was scheduled to have subsequent surgery to remove the device's tip.The patient reportedly survived the procedure.It is unknown whether the device is being returned to the manufacturer for evaluation.Multiple attempts have been made from a philips representative to the physician in order to obtain more information about the procedure and details of the alleged malfunction; no additional information has been made available.

• 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: 10748173
• Report Number: 1721279-2020-00215
• Device Sequence Number: 3933083
• Product Code: DQY
• UDI-Device Identifier: 00813132020675
• UDI-Public: (01)00813132020675(17)220205(10)FQP20B03A
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 10/01/2020

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: 02/05/2022
• Device Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: FQP20B03A
• 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: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO CONCOMITANT PRODUCTS REPORTED
• Outcome Attributed to Adverse Event: Required Intervention