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

Catalog Number	400SMTSFT0308
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/31/2019
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
During preparation for a coil embolization procedure, the physician was unable to advance a penumbra smart coil (smart coil) out of its introducer sheath on the back table.It was reported that the smart coil was stuck inside its introducer sheath and would not advance out.The issue with the smart coil occurred prior to use and, therefore, the smart coil was not used in the procedure.The procedure was completed using a new smart coil.
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 at approximately 5.0 cm, 42.0 cm, 71.0 cm and 141.0 cm from the proximal end.The smart coil pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and undamaged.After resheathing the smart coil to its proper location, the smart coil was able to advance through its introducer sheath and a demonstration microcatheter.Resistance was experienced when the pusher assembly kinks were advanced into the introducer sheath and microcatheter.Conclusions: evaluation of the returned smart coil revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the mid-joint is retracted through the introducer sheath friction lock, resistance will likely be experienced while attempting to advance the device.If the smart coil is forcefully advanced against resistance, damage such as kinks may occur.Further investigation revealed additional kinks on the pusher assembly.These kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8768128
• Report Number: 3005168196-2019-01319
• Device Sequence Number: 2359865
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• Combination Product (Y/N): Y
• Initial Reporter Country: LE
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019
• 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: 06/07/2023
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F83939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005