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	Foreign Body Embolism (4439)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The intended procedure was an atherectomy, with bilateral pelvic and left lower extremity runoff via angiography.During the procedure, the physician chose a quick-cross support catheter to treat the patient.Upon moving the quick-cross within the patient's superficial femoral artery (sfa), it was noted that a portion of the catheter had broken off (approximately 10 cm long).In order to remove from the patient, the introducer sheath was upsized from a 5f to a 6f, the guide wire was removed, and a 10 mm snare was inserted into the left iliac artery.The catheter portion was successfully snared and removed.The patient did not feel discomfort and there was no reported patient harm.Further attempts for atherectomy were aborted.This report captures the quick-cross for shaft separation, requiring intervention for removal.
Additional Manufacturer Narrative
Patient's date of birth: unk.Patient's ethnicity/race: unk.User facility report number: # (b)(4).The device was not returned, thus no investigation could be completed.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 an alleged death or deterioration in the state of the health of any person.

• 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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 14783650
• Report Number: 1721279-2022-00119
• Device Sequence Number: 5058527
• Product Code: DQY
• UDI-Device Identifier: 00813132020675
• UDI-Public: (01)00813132020675(17)230526(10)FQP21E25A
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K033678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

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: 05/26/2023
• Device Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: FQP21E25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10 MM SNARE MANUFACTURER UNK; COOK MEDICAL 6F ANSEL GUIDING SHEATH; COOK MEDICAL ANSEL 5F GUIDING SHEATH; GUIDE CATHETER MANUFACTURER/SIZE AND USE UNK; GUIDE WIRE, MANUFACTURER AND SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 56 KG