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

Model Number	400SMTXSFT0208
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	12/23/2019
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.This report is associated with mfr report numbers: 3005168196-2020-00060, 3005168196-2020-00061.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right sinus transversus using penumbra smart coils (smart coils), a non-penumbra catheter, and a non-penumbra microcatheter.It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician implanted fifteen coils into the target vessel using the microcatheter.While attempting to advance a smart coil within its introducer sheath, the physician experienced resistance and the smart coil remained stuck in its initial position; therefore, it was removed.The procedure continued using additional coils.While advancing the nineteenth smart coil into the microcatheter, the physician encountered resistance and the smart coil became stuck in the hub of the microcatheter; therefore, it was removed.The procedure continued using additional coils.While advancing the twenty-sixth smart coil into the microcatheter, the physician encountered resistance and the smart coil became stuck in the hub of the microcatheter; therefore, it was removed.The procedure was completed using the same microcatheter, additional smart coils, and other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the first returned smart coil revealed a distal kink on the introducer sheath.If a rotating hemostasis valve (rhv) is over-tightened onto the introducer sheath, damage such as this may occur.During functional testing, resistance was experienced while attempting to advance the smart coil through the kink in the introducer sheath and the smart coil could not advance any further.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the reported complaint.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the smart coil was able to advance through its introducer sheath with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.Subsequently, the smart coil was advanced through a demonstration microcatheter without an issue.Further evaluation revealed a pusher assembly kink.This kink was likely incidental to the reported complaint.Evaluation of the third returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the smart coil was able to advance through its introducer sheath with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.Subsequently, the smart coil was advanced through a demonstration microcatheter without an issue.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.This report is associated with mfr report numbers: 1.3005168196-2020-00060.2.3005168196-2020-00061.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: 9593239
• Report Number: 3005168196-2020-00062
• Device Sequence Number: 374651
• Product Code: HCG
• UDI-Device Identifier: 00814548015552
• UDI-Public: 00814548015552
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 12/25/2019
• 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: 01/02/2024
• Device Model Number: 400SMTXSFT0208
• Device Catalogue Number: 400SMTXSFT0208
• Device Lot Number: F87779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/25/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005