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

Catalog Number	400SMTXSFT0101
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 to treat an acute ruptured basilar tip aneurysm using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil out of its introducer sheath and into a non-penumbra microcatheter.After several failed attempts to advance the coil out of its introducer sheath, the introducer sheath containing the smart coil was removed.The procedure was successfully completed using another smart coil and additional coils without any issues.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The penumbra smart coil (smart coil) pusher assembly was kinked approximately 9.0, 12.0, and 27.0 cm from the proximal end.The embolization coil had multiple offset coil winds along its length.Evaluation of the returned smart coil revealed that the embolization coil had multiple offset coil winds along its length.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, the embolization coil can begin to take shape within the hub resulting in the reported offset coil winds.These offset coil winds likely contributed to the inability to advance the embolization coil into the non-penumbra microcatheter.Further evaluation revealed that the pusher assembly was kinked in multiple locations.This damage was likely a result of forcefully advancing the smart coil against resistance after the coil became stuck.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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: 6725103
• Report Number: 3005168196-2017-01200
• Device Sequence Number: 1246706
• Product Code: HCG
• UDI-Device Identifier: 00814548015163
• UDI-Public: 00814548015163
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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
• Operator of Device: Physician
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: 400SMTXSFT0101
• Device Lot Number: F72369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1