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

Catalog Number	400SMTXSFT1H04
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
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 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 the hub of a non-penumbra microcatheter; therefore, the introducer sheath containing the smart coil was removed.The procedure was completed using additional smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked approximately 41.0, 54.0, and 137.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Evaluation of the smart coil revealed that the pusher assembly was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage, such as this may occur.The kink in the pusher assembly prevented the smart coil from being advanced through a demonstration microcatheter during the functional test.The root cause of the initial resistance could not be determined.The smart coil was attempted to be advanced through a demonstration microcatheter.While advancing the smart coil's pusher assembly through the introducer sheath, resistance was encountered due to the distal kink in the pusher assembly and the smart coil could not be advanced through the microcatheter.The non-penumbra microcatheter referred to 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7119096
• Report Number: 3005168196-2017-02207
• Device Sequence Number: 1156153
• Product Code: HCG
• UDI-Device Identifier: 00814548015248
• UDI-Public: 00814548015248
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 05/23/2022
• Device Catalogue Number: 400SMTXSFT1H04
• Device Lot Number: F77296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1