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

Model Number	518-036
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A proximal portion of the quick-cross was returned and evaluated by a cross functional team.When intact, the quick-cross has three distal bands present; however, the two most distal bands were missing from the returned portion.The device was torn 25 mm distal of the proximal band.After review/measurement of the device specification, it was determined that approximately 75 mm was missing from the distal tip.The distal edge of where the device broke was jagged, indicating that it had been pulled apart.There was a zipper-like marking observed along the outside of the quick-cross's distal end.Due to the condition of the returned portion of the quick-cross catheter, it is likely that excessive forces were applied during removal from patient, causing the device separation.This has been determined to be a use related failure.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.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the patient's proximal iliac artery.A spectranetics quick-cross support catheter was used to treat the patient.During the procedure, the distal portion of the catheter broke off inside the patient and was unable to be retrieved.The distal portion was stented to the vessel wall to prevent movement within the vasculature.The patient survived the procedure.This report captures the quick-cross catheter which separated inside the patient, requiring intervention but unable to be retrieved.
Event or Problem Description
Additional information stated that some resistance was felt when removing the quick-cross catheter from the patient.
Additional Manufacturer Narrative
B5: additional information provided by the physician on 30nov2022.G3/h6: further investigation determined there was no design or production process related failure identified.The physician felt some resistance when removing the quick-cross catheter and was unsure what it got caught up on, but was likely the severely calcified lesion.Conclusion code 50 has been added; conclusion code 61 remains accurate.Due to patient condition, excessive force was required to remove the device, causing device separation.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: 15495753
• Report Number: 1721279-2022-00173
• Device Sequence Number: 5070566
• Product Code: DQY
• UDI-Device Identifier: 00813132020675
• UDI-Public: (01)00813132020675(17)240801(10)FQP22H01A
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 08/01/2024
• Device Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: FQP22H01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: BOSTON SCIENTIFIC AMPLATZ 0.035 GUIDE WIRE; TERUMO 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White