MAUDE Adverse Event Report: ATHEROMED INC 2MM X 149 CM PHOENIX ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	P22149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempt to obtain "patient weight" was unsuccessful as the weight was not recorded.All reasonably known patient information is included in this report.Additional information: the physician wired down to the anterior tibial (at) with a light support wire*.The target lesion was in the proximal at.This patient had an abrupt junction between the at and the tibial peroneal trunk (tpt) which made the takeoff of the at steep.The guidewire was biasing toward the carina of the tpt/at junction and could have been sub-intimal at this location.This is where a perforation occurred during atherectomy.Per the analysis of the 0.14 guidewire*, vessel tissue was found wrapped around the.014 guidewire.Treatment was not completed by the procedure.No damage was noted during prep.Resistance was felt on the 2nd pass (only made 2 passes).Device appeared intact after removal from the patient and no damage was observed.The catheter was removed with difficulty first, after multiple attempts, to buddywire, exchange through crossing catheter, balloons, physician finally had to remove the guidewire.Nothing would advance past a certain point on the wire.* the support wire noted is a guide wire distributed by this manufacturer and an initial report was submitted separately to the fda under mdr 2939520-2017-00074 on 09-01-2017 (b)(4).No tests/laboratory data was available.Other relevant history: no information was available.A serial number is not applicable to this device.The implant or explant dates are not applicable to this device.The catheter was returned for analysis.Visual inspection of the catheter revealed no damage; both were found to be fully functional.Any resistance during the case must have been caused by tissue attached to the guidewire.The catheter and handle worked as intended.Foreign material (vessel tissue) was present on the guidewire which prevented the passage of the atherectomy catheter and balloon catheters.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.
Event or Problem Description
It was reported for a therapeutic peripheral procedure the user plugged in atherectomy catheter device, flushed, made one pass that was fine, and came back to make the second pass.The atherectomy device almost stopped.The physician pulled back slightly and got it to work.When they tried to advance, it was like there was a blockage.They stopped, pulled the atherectomy device and did angiogram and saw the there was a substance on the wire.They then tried to advance a balloon down the wire and it would not go.They tried advancing it [the catheter] again but was unable.When they pulled the wire they saw something on the wire that had been preventing the pass.Patient experienced an event of perforated artery at anterior tibial.Patient was released as expected in stable condition.On (b)(6) 2017 the manufacturer's representative reported the patient was admitted to the hospital post-procedure.Vessel: 99% occlusion, located anterior tibial, moderately calcified this event is being reported because there was a patient event during the procedure.

• Brand Name: 2MM X 149 CM PHOENIX ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): ATHEROMED INC; 1455 adams drive, suite 1120; menlo park CA 94025
• MDR Report Key: 6840266
• Report Number: 2939520-2017-00073
• Device Sequence Number: 11042239
• Product Code: MCW
• UDI-Device Identifier: 00845225002657
• UDI-Public: (01)00845225002657(17)190430(10)04051709
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143328
• 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): 08/02/2017

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: 04/30/2019
• Device Model Number: P22149
• Device Catalogue Number: P22149K
• Device Lot Number: 04051709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 69 YR