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

Catalog Number 400SMTHXSFT0103

Device Problems Out-Of-Box Failure (2311); Defective Device (2588); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2017-01273, 3005168196-2017-01274.

Event Description

The patient was undergoing a coil embolization procedure in the posterior communicating artery using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the nurse opened the packaging of the first smart coil and noticed that the coil was already outside of its introducer sheath.Therefore, the coil was not used in the procedure and did not come into contact with the patient.A new smart coil was then opened for the procedure.The physician deployed and detached the smart coil into the target vessel using a non-penumbra microcatheter without an issue.Next, the physician deployed the last smart coil into the target vessel without any mention of resistance but was unable to detach the coil using the handle.Therefore, the smart coil was removed and the procedure ended as the physician indicated that the aneurysm had enough packing density.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The penumbra smart coil (smart coil) was returned with the embolization coil within the introducer sheath.The pet lock was intact on the proximal end of the pusher assembly.The introducer sheath friction lock was present and undamaged.The embolization coil was intact with the pusher assembly.During functional analysis, the smart coil was advanced out of its introducer sheath and re-sheathed without issue.The pusher assembly mid-joint was seated inside the introducer sheath friction lock without issue during re-sheathing.Evaluation of the returned devices revealed that the first smart coil was returned with the embolization coil contained within the introducer sheath.The smart coil was advanced out of its introducer sheath and re-sheathed without issue.The pusher assembly mid-joint was seated inside the introducer sheath friction lock without issue during re-sheathing.The root cause of the reported introducer sheath issue could not be determined.Further evaluation revealed that the second smart coil had a broken pet lock, the embolization coil was intact with the pusher assembly, and a clear hardened substance was inside and around the ddt.A broken pet lock indicates that a pull force was applied to the proximal end of the pull wire, typically in an attempt to detach the coil.During functional analysis, the pull wire was manually retracted out of the pusher assembly hypo-tube and the distal end of the pull wire retracted out of the ddt, but the embolization coil did not detach.The clear hardened substance likely prevented the proximal constraint sphere from escaping the ddt, which prevented the embolization coil from detaching.The penumbra smart coil detachment handle and the non-penumbra microcatheter mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually and functionally inspected during incoming quality 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: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6756744
• MDR Text Key: 81504052
• Report Number: 3005168196-2017-01272
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F73176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• 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