MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL DETACHMENT HANDLE; HCG, KRD

Catalog Number SCH1

Device Problems Separation Failure (2547); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2018-02049.

Event Description

The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a penumbra smart coil handle (handle) and penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil in the target vessel using a non-penumbra microcatheter and attempted to detach it using a handle; however, the coil failed to detach.After two failed attempts, the physician manually pulled the smart coil¿s black alignment zone (pet lock) apart; however, the smart coil was still coming back with the pusher assembly when the physician pulled back to remove.It was reported that after pulling approximately one and half centimeters of the smart coil inside the microcatheter, the smart coil unintentionally detached.Therefore, the physician tried to push the smart coil with its pusher assembly but it did not advance past a certain point.The physician then tried to push the smart coil with a wire but the smart coil did not advance past the same point in the microcatheter.Therefore, the physician pulled the catheter back, leaving one and half centimeters of the smart coil tail outside the target vessel.The procedure was completed by holding the tail of the smart coil against the wall of the vessel using a stent device.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7980385
• MDR Text Key: 124320171
• Report Number: 3005168196-2018-02050
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCH1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR