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

Catalog Number	400SMTXSFT3H08
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 noticed that a penumbra smart coil (smart coil) would not advance through and exit out of its introducer sheath.It was reported that the physician attempted to advance the smart coil into a bowl of saline but the smart coil was stuck in its introducer sheath.The issue with the smart coil occurred prior to use and, therefore, it was not used in the procedure.The procedure was completed using another smart coil.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.After the introducer sheath was removed from its pusher assembly a neckdown zone distal to the friction on the sheath was noticed.Upon functional testing, resistance was encountered while attempting to advance the returned smart coil from its returned position and the smart coil could not be advanced any further.The introducer sheath was removed from its pusher assembly by the penumbra investigator.The smart coil was re-sheathed, and the embolization coil was able to be advanced and retracted through its introducer sheath without an issue.Conclusions: evaluation of the returned smart coil confirmed the difficulty experienced when attempting to advance the coil.Further evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the pusher assembly mid-joint is retracted to beyond its original position proximal to the introducer sheath friction lock, resistance may be encountered during advancement.After unseating the mid-joint from the friction lock, the smart coil was able to advance through a demonstration microcatheter without issue.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.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: 8758358
• Report Number: 3005168196-2019-01300
• Device Sequence Number: 14027394
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 06/05/2019
• 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: 08/08/2023
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F85167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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