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

Catalog Number 400SMTXSFT0410

Device Problems Physical Resistance (2578); Malposition of Device (2616); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 in the basilar artery using penumbra smart coils (smart coils).During the procedure, while deploying the last smart coil in the target vessel using another manufacturer's microcatheter, the physician noticed that part of the smart coil was protruding out of the aneurysm and running up part of the posterior cerebral artery (pca).The physician then attempted to retract the smart coil back into the microcatheter.However, resistance was encountered and the coil would not pull back into the microcatheter.The physician noticed that the smart coil appeared to be knotted, which may have prevented it from being pulled back.Therefore, the physician pulled the microcatheter back and then the smart coil with it, out of the aneurysm.The procedure was completed at this point.It should be noted that a rotating hemostasis valve (rhv) was used during the procedure.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly; the pusher assembly was kinked in multiple locations; the embolization coil had a knot in it and was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed that the smart coil¿s embolization coil had a knot in it.The root cause of this damage could not be determined.However, the knot likely contributed to the coil not being able to retract into the microcatheter.Further evaluation revealed that the pusher assembly was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging of the device for return.Smart coils are 100% functionally tested during in-process inspection.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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5831895
• MDR Text Key: 50728338
• Report Number: 3005168196-2016-01078
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• 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: 06/28/2016

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: 12/26/2020
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F67096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2015
• 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