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

Model Number	400SMTXSFT0208
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
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: 3005168196-2020-02321.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastrointestinal artery using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, a smart coil became stuck in the distal tip of its introducer sheath and would not advance any further.Therefore, it was removed.The physician then advanced a new smart coil through the microcatheter; however, the smart coil became stuck in the middle of the microcatheter.The physician then decided to remove the smart coil.While retracting the smart coil, it unintentionally detached inside of the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.The procedure was completed using a new smart coil and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by penumbra distributor on (b)(6) 2020: 1.Section b.Box 5.Describe event or problem results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 26.5, 57.5 and 131.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds on its proximal end.Conclusions: evaluation of the first returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, the embolization coil may begin to take shape within the hub and resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the offset coil winds.During the functional test, the smart coil was unable to advance at all within its introducer sheath due to resistance caused by the offset coil winds.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the reported complaint.Evaluation of the second returned smart coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.During the functional test, the smart coil was unable to be advanced out of its introducer sheath due to resistance cause by the offset coil winds.The root cause of the resistance experienced during the procedure could not be determined.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the reported complaint.Evaluation of the third returned smart coil confirmed that the embolization coil was detached from its pusher assembly and was stuck within the non-penumbra microcatheter.The embolization coil was unable to be removed from the non-penumbra microcatheter.The root cause of the detached embolization coil could not be determined.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: 1.3005168196-2020-02321.2.3005168196-2021-00139.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastrointestinal artery using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, a smart coil became stuck in the distal tip of its introducer sheath and would not advance any further.Therefore, it was removed.The physician then advanced a new smart coil through the microcatheter; however, the smart coil became stuck in the middle of the microcatheter.The smart coil was therefore, removed.While advancing another smart coil, the same issue occurred, and the coil became stuck in the middle of the microcatheter.The physician then decided to remove the smart coil; however, while retracting the smart coil, it unintentionally detached inside of the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.The procedure was completed using a new smart coil and microcatheter.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: 11045668
• Report Number: 3005168196-2020-02322
• Device Sequence Number: 19506014
• 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): 11/27/2020
• 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: 04/09/2024
• Device Model Number: 400SMTXSFT0208
• Device Catalogue Number: 400SMTXSFT0208
• Device Lot Number: F89525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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