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

Catalog Number 400SMTXSFT0308

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2017-02312, 3005168196-2017-02313.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the right gastro-epiploic artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician placed three initial non-penumbra coils into the proximal side of the parent vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil out of its introducer sheath and into the microcatheter, the physician experienced resistance and the smart coil would not advance out.Therefore, the smart coil was removed and a new smart coil was opened.Next, the physician advanced the new smart coil into the target vessel and attempted to detach it using the handle but was unsuccessful.After two failed attempts, the physician opened a new handle and the smart coil was successfully detached.The procedure was then completed using five new smart coils, seven additional coils, the same microcatheter and the second handle.There was no report of adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• 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: 7154779
• MDR Text Key: 96347349
• Report Number: 3005168196-2017-02314
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015361
• UDI-Public: 00814548015361
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 400SMTXSFT0308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• 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: 83 YR