MAUDE Adverse Event Report: SPECTRANETICS CORPORATION PHOENIX 2.4MM X 130CM, 7F DEFLECTING ATHERECTOMY SYSTEM; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	PD24130K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a phoenix catheter was used in a therapeutic peripheral procedure in a severely calcified lesion.First, the catheter was used to treat the proximal sfa, and due to the severe calcification, an inova stent was placed.Next, the plan was to treat the distal segment of the popliteal artery.Because of the hard calcification, a 3 mm balloon was placed over the guidewire for dilatation.Then, the catheter was inserted over the guidewire to treat the popliteal artery.After, the guidewire was removed and under fluoroscopy, contrast medium leakage (evidence of perforation) was noted.An attempt was made to replace with a 0.035 guidewire distal to the perforation, but images showed the guidewire had looped, and exited the vessel, worsening the perforation.Therefore, it was decided to bypass the vessel with a vein.Today, the patient is doing fine and the leg is warm with good pulses.This adverse event is being submitted because the phoenix catheter was in the area when a perforation occurred, and required additional intervention.There was no alleged malfunction with the phoenix catheter.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2: date of birth not provided.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks d1 & g: address listed reflects the specification developer.Blocks e1 & g2: country is germany.Blocks h3 & h6: the phoenix catheter was not returned for evaluation, thus no returned product investigation was performed.Blocks h7 & h9: do not apply to this submission.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.
Additional Manufacturer Narrative
Blocks d9 & h3: the phoenix catheter was returned for evaluation.Block h3: visual inspection found no unusual characteristics of the catheter.The cutter and flex capacitor was stalled; however, this is a normal occurrence due to heavy biologics present.Additionally, there was a small tear on the catheter shaft but no sharp edges were observed.During functional testing, the handle was tested at 11800 rpm and worked as intended.Block h6: based on the evaluation, the phoenix catheter performed as intended.There was no visible damage or mechanical failure that could have caused the perforation.Further, a non-philips dilation balloon was also in the area when the perforation occurred, which could have caused the perforation, but cannot be confirmed.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: PHOENIX 2.4MM X 130CM, 7F DEFLECTING ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: danielle bullock ; 9965 federal drive; colorado springs, CO 80921 ; 858720-4125
• MDR Report Key: 19265696
• Report Number: 3007284006-2024-00092
• Device Sequence Number: 20690506
• Product Code: MCW
• UDI-Device Identifier: 00845225003197
• UDI-Public: (01)00845225003197(12)241231(10)03282210
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 12/31/2024
• Device Model Number: PD24130K
• Device Catalogue Number: PD24130K
• Device Lot Number: 03282210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: CORDIS: 7F INTRODUCER SHEATH.; TERUMO: .035 GUIDEWIRE.; VOLCANO: 0.014 PHOENIX GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White