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

Catalog Number 400SMTHXSFT2H08

Device Problems Material Frayed (1262); Retraction Problem (1536); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

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.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil into the patient using a non-penumbra microcatheter but decided to remove the coil and use a smaller sized coil.While retracting the smart coil back through microcatheter, the physician encountered slight resistance.Upon removal, the physician noticed that the smart coil was frayed and slightly stretched.Therefore, the procedure was completed using new smart coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The penumbra smart coil (smart coil) was received tightly wound around itself.The embolization coil was damaged throughout its length.The pusher assembly was kinked and bent along its length.During functional analysis, the introducer sheath was back loaded onto the smart coil pusher assembly but the embolization coil was unable to be advanced out of the introducer sheath.Evaluation of the returned smart coil revealed that the embolization coil had offset coil winds along its length and was stretched.If an attempt is made to retract the embolization coil against resistance, this type of damage can occur.Further evaluation revealed the pusher assembly was kinked and bent along its length.These damages were likely incidental and occurred during packaging for return to penumbra.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.As a result, the root cause of the initial resistance could not be determined.Penumbra coils are 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: 6846816
• MDR Text Key: 85630959
• Report Number: 3005168196-2017-01469
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016016
• UDI-Public: 00814548016016
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: 400SMTHXSFT2H08
• Device Lot Number: F73169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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