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

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that the manufacturer could not determine which of the following lot numbers corresponded to the smart coil that just became stuck inside the microcatheter and which lot number corresponded to the smart coil that became stuck in the microcatheter and became crinkled: lot #: f75510, catalog #: 400smtxsft0306, udi #: (b)(4), manufacture date: 04/10/2017, expiration date: 04/09/2022.Lot #: f72334, catalog #: 400smtxsft2h06, udi #: (b)(4), manufacture date: 10/18/2016, expiration date: 10/17/2021.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 number: 3005168196-2018-00023.

Event Description

The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician jailed a non-penumbra microcatheter in the aneurysm using a non-penumbra stent retriever then deployed and detached two initial smart coils.While the physician was attempting to advance a new smart coil (3x6 extra soft) through the microcatheter, the coil advanced about the length of the introducer sheath into the microcatheter and then became stuck.The hospital staff checked to see if there was any gap between the introducer sheath and the hub of the rotating hemostasis valve (rhv) and did not see a gap.Therefore, the smart coil was removed and a new smart coil (2.5x6 complex extra soft) was opened.While attempting to advance the new smart coil through the microcatheter, the physician focused on the introducer sheath/hub junction and did not observe any gap or coiling within the hub; however, the smart coil became stuck at the same position and was removed.It was reported that the pusher assembly of one of the two smart coils that were removed was crinkled.The procedure ended at this point because the physician believed there was sufficient packing density.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the first smart coil evaluated was kinked approximately 5.0, 12.0, and 126.0 cm from the proximal end.Conclusions; the first smart coil evaluated revealed some pusher assembly kinks.During functional testing, the smart coil was able to be advanced through demonstration microcatheter and out the distal tip with only minor resistance.These pusher assembly kinks may have been due to attempting the advance the device against the reported resistance or during packaging for return to penumbra.The second smart coil evaluated revealed a crinkled polymer section of the pusher assembly along with several other pusher assembly kinks.The coil also had offset coil winds.These damages were likely a result of forcefully advancing the embolization coil against resistance.If the introducer sheath is not properly aligned in the hub prior to advancement, resistance may be encountered.Forcefully advancing the device against this resistance will likely result in offset coil winds and pusher assembly kinks.During functional testing, the device was unable to be advanced past the hub of the demonstration microcatheter.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Manufacturer Narrative

(b)(4).This report is associated with mfr report number: 3005168196-2018-00023.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7162942
• MDR Text Key: 96475984
• Report Number: 3005168196-2018-00022
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,12/04/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 06/26/2018; 01/14/2005
• Supplement Dates FDA Received: 07/03/2018; 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR