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

Model Number	400SMTXSFT0102
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
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 number: 3005168196-2021-02007.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar tip using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, while advancing a smart coil through the microcatheter, the smart coil became stuck approximately three-fourths of the microcatheter.Therefore, the smart coil was removed.Afterwards, while advancing another smart coil through the microcatheter, the same issue occurred.The smart coil became stuck in the microcatheter; therefore, the smart coil and microcatheter were removed.The procedure was completed using three new smart coils and a new velocity delivery microcatheter (velocity).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed the device was returned advanced through its introducer sheath and had offset coil winds on the embolization coil, and pusher assembly kinks throughout its length.If the device is forcefully manipulated against resistance, damage such as pusher assembly kinks and offset coil winds may occur.During functional testing, the smart coil was re-sheathed from its returned position within the introducer sheath with resistance due to the offset coil winds and pusher assembly kink.Subsequently, the smart coil was advanced through the introducer sheath with resistance but was unable to advance through a demonstration microcatheter due to the pusher assembly kink on the proximal end.The root cause of resistance during the procedure could not be determined.Some of the observed damages may be incidental to the reported complaint and may have occurred during packaging the device for return to penumbra.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kinks observed near the mid-joint.During functional testing, the smart coil was only able to advance slightly from its returned position within the introducer sheath with resistance before additional resistance was encountered due to the pusher assembly kinks, and the coil could not advance any further.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 number: 3005168196-2021-02007 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: 12457570
• Report Number: 3005168196-2021-02008
• Device Sequence Number: 19143600
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• Combination Product (Y/N): Y
• 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): 09/10/2021
• 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: 07/26/2025
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F99145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/11/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Date Report Sent to FDA: 01/01/2005