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

Catalog Number	400SMTSTD0515
Medical Device Problem Codes	Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician advanced and deployed a smart coil in the aneurysm using a non-penumbra microcatheter.However, the smart coil was not well compacted within the aneurysm; therefore, the physician retracted and re-advanced the smart coil multiple times with no success.The smart coil was then removed and a vascular reconstruction device (vdr) was placed.Next, the physician attempted to advance the previous smart coil through the non-penumbra microcatheter; however, resistance was experienced and therefore, the smart coil was removed.The procedure was completed using the same non-penumbra microcatheter and new smart coils.The physician reported maintaining continuous flush and not using a rotating hemostasis valve.There was no report of an adverse effect to the patient.
Additional 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 approximately 79.0 cm from the proximal end of the pusher assembly.The pull wire was visible protruding from the distal detachment tip (ddt).The penumbra investigator was able to drag the pull wire further out from the ddt.The embolization coil had offset coil winds along its length.There was slight discoloration at the distal tip of the pull wire.Conclusions: evaluation of the device revealed the pull wire was protruding approximately 1.0 mm out of the distal tip of the ddt while the pet bump was present within the catch feature.The penumbra investigator was able to drag the pull wire further distally suggesting the pet bump was sliding proximal along the pull wire.This may be due to compressive forces encountered when repeatedly attempting to place the embolization coil in addition to added resistance when manipulating the smart coil through a stent.Further evaluation revealed slight discoloration at the distal tip of the pull wire.This is likely is where the pet bump was present prior to slipping proximally on the pull wire.Further evaluation revealed a bent pusher assembly and offset coil winds along the length of the embolization.This bend is likely incidental and may have occurred during packaging for return to penumbra facilities.The offset coil winds are likely a result of repeated attempts to place the coil within the aneurysm in addition to removing the coil entirely before more attempts to place the coil.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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6239380
• Report Number: 3005168196-2017-00025
• Device Sequence Number: 784166
• Product Code: HCG
• UDI-Device Identifier: 00814548014647
• UDI-Public: 00814548014647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2016

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
• Operator of Device: Physician
• Device Expiration Date: 07/11/2021
• Device Catalogue Number: 400SMTSTD0515
• Device Lot Number: F70557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1