MAUDE Adverse Event Report: PHILIPS VOLCANO PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P18130K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.The manufacturer's guide wire (phoenix) did not cause or contribute to the perforation.No information available.Not applicable for this device.The implanted or explanted dates are not applicable to this device.Not applicable for this device.Country is (b)(6).The phoenix catheter system was discarded and not returned for evaluation, thus no returned product investigation was performed.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
It was reported that during a peripheral procedure, the manufacturer's catheter was flushed with normal preparation.The manufacturer's catheter was easily loaded on to a v18 guidewire inside the distal left anterior tibialis with no complications.Then, the v18 guidewire was changed via a quickcross to the manufacturer's guidewire.The manufacturer's catheter was placed into the proximal anterior tibialis and treated two short lesions in the proximal part with two passages.At the end of the second lesion, the manufacturer's catheter had a slight resistance and was taken back.Follow-up angiography images showed a perforation, which was treated twice with a 3 min dilatation with a 2mm/4 cm balloon and a 3mm/8cm amphirion.After treatment, the patient had good result.This adverse event is being submitted because the patient experienced perforation and required intervention.
Additional Manufacturer Narrative
Internal reference: (b)(4).Block h6: added code 4755 (part/component/sub-assembly term not applicable) and 4614 (serious injury/illness/impairment).

• Brand Name: PHOENIX CATHETER SYSTEM, 1.8MM X 130CM, 5F (KIT)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11742295
• Report Number: 2939520-2021-00021
• Device Sequence Number: 4138462
• Product Code: MCW
• UDI-Device Identifier: 00845225002619
• UDI-Public: (01)00845225002619(17)230131(10)01112112
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K140944
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 01/31/2023
• Device Model Number: P18130K
• Device Catalogue Number: 400-0200.290
• Device Lot Number: 02262102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: MERIT MEDICAL: 5F INTRODUCER SHEATH; PHILIPS: 0.014" PHOENIX GUIDE WIRE; PHILIPS: QUICK-CROSS GUIDE CATHETER SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR