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

Catalog Number 400SMTHXSFT0102

Device Problems Failure to Advance (2524); Physical Resistance (2578); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2017-00646.

Event Description

The patient was undergoing a coil embolization procedure in the anterior cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached three non-penumbra coils and one smart coil into the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician encountered resistance and was unable to advance the coil pass the hub of the microcatheter.The physician then removed the smart coil and attempted to advance it out of its introducer sheath for inspection.While advancing the smart coil out, the physician felt a "grating" or "scratching" touch before the coil was completely out of its sheath.Therefore, the physician decided to open a new smart coil and attempted to advance it through the same microcatheter.However, the physician was unable to advance the coil pass the hub of the microcatheter.The physician then removed the smart coil and was able to advance it out of its introducer sheath while outside of the patient.Next, the physician flushed the microcatheter and made another attempt to advance the same smart coil but encountered resistance.Therefore, the smart coil was removed and the procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The pet lock was intact on the proximal end of the penumbra smart coil (smart coil).The pusher assembly was kinked approximately 98.5 cm from the proximal end.The embolization coil was intact with its pusher assembly and the embolization coil windings were offset.During functional analysis, the smart coil was unable to advance through a demonstration microcatheter.Evaluation of the returned devices revealed that both smart coils'' embolization coil windings were offset.If the introducer sheath is not fully seated inside the microcatheter hub, the embolization coil may start taking shape inside the hub, and damage such as this may occur.The offset coil winds likely further contributed to the resistance experienced when attempting to re-advance the smart coils.Further evaluation of the first smart coil revealed that the pusher assembly was kinked.This kink was likely incidental and may have occurred while packaging the device for return.Furthermore, evaluation of the second smart coil revealed that the pet lock was broken on the proximal end of the pusher assembly.This type of damage likely occurred due to forceful handling during use.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 6526210
• MDR Text Key: 74020831
• Report Number: 3005168196-2017-00645
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/06/2021
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F72675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 11/18/2017
• Supplement Dates FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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