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

Catalog Number	400SMTXSFT2H06
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
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 pusher assembly was kinked approximately 8.0, 56.0, and 137.0 cm from its proximal end.The embolization coil was undamaged and intact with its pusher assembly.Conclusions: evaluation of the returned smart coil confirmed resistance while attempting to advance its pusher assembly through its introducer sheath.During the functional test, the smart coil was able to be advanced out of its sheath and through a demonstration microcatheter with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.Further evaluation revealed pusher assembly kinks.If the smart coil is mishandled during advancement against resistance, damage such as kinks may occur.Some of the kinks were likely incidental to the reported complaint.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, the physician experienced resistance while advancing a smart coil within the introducer sheath; therefore, it was removed.It was also reported that the physician attempted to advance the smart coil out of its introducer sheath on the back table, but it would not advance.The procedure was completed using a new smart coil.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: 9279630
• Report Number: 3005168196-2019-02068
• Device Sequence Number: 2181475
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 10/10/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F85551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005