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

Catalog Number	400SMTHXSFT4H15
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The embolization coil was in a knot and intact with its pusher assembly.The pusher assembly was kinked approximately 18.0 cm from the proximal end.Conclusions: evaluation of the returned device revealed that the smart coil¿s embolization coil was in a knot.If the introducer sheath is not properly seated in the hub of the microcatheter when the smart coil is being advanced, the smart coil may begin to take shape in the hub, and resistance may be encountered.Manipulation of the smart coil while it was taking shape inside the hub may have caused it to form a knot, which would have further contributed to the resistance experienced by the physician.Further evaluation revealed that the pusher assembly was kinked.This kink was likely incidental and may have occurred while packaging the device for return.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil out of its introducer sheath and into a non-penumbra microcatheter, the physician advanced approximately three to five centimeters of the coil and then encountered resistance.Subsequently, the physician was unable to advance the smart coil further and therefore, removed the coil.The procedure was then successfully completed using four new smart coils and the same non-penumbra microcatheter.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: 6294017
• Report Number: 3005168196-2017-00136
• Device Sequence Number: 10933235
• Product Code: HCG
• UDI-Device Identifier: 00814548017389
• UDI-Public: 00814548017389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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
• Operator of Device: Physician
• Device Expiration Date: 11/06/2021
• Device Catalogue Number: 400SMTHXSFT4H15
• Device Lot Number: F72656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 02/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR