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

Catalog Number	400SMTSFT0406
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 31.0 cm from the proximal end and had a torque device distal to the fractured location.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first returned penumbra smart coil (smart coil) revealed that the embolization coil winds were offset and the pusher assembly was severely kinked.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, resistance may be encountered.If the device is further advanced against resistance, damage such as offset coil winds may occur.Further evaluation of the returned device revealed that the pusher assembly was severely kinked.This kink likely occurred due to forceful advancement against resistance.Prior to attempting to functionally test the smart coil through a demonstration microcatheter, the severe kink in the pusher assembly could not be advanced through the introducer sheath and, therefore, the smart coil could not be functionally tested through a demonstration microcatheter.Evaluation of the second returned smart coil revealed that the pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as a kink may occur.Subsequently, if the kink is attempted to be straightened, damage such a fracture may occur.Due to the fracture in the pusher assembly the smart coil could not be functionally tested through a demonstration microcatheter.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually 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.This report is associated with mfr report number: 3005168196-2018-00056.
Event or Problem 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 successfully placed two coils using a non-penumbra microcatheter.The physician then was unable to advance two smart coils into the microcatheter, and therefore the smart coils were removed.The procedure was then completed using the same microcatheter and additional coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7169864
• Report Number: 3005168196-2018-00057
• Device Sequence Number: 1476232
• Product Code: HCG
• UDI-Device Identifier: 00814548015071
• UDI-Public: 00814548015071
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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
• Report Date (Section B): 12/07/2017

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: 05/08/2021
• Device Catalogue Number: 400SMTSFT0406
• Device Lot Number: F69256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR