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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2021
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
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.During the procedure, two other coils were successfully implanted into the target location.While attempting to advance a smart coil through its introducer sheath, it would not advance past its initial position.Therefore, the smart coil was removed.After advancing approximately half of the next smart coil into the location, the vessel went into spasm and the coil could not be implanted.Therefore, the smart coil was removed.Angiography showed that bleeding had stopped; therefore, no additional coils were needed and the procedure ended.The relationship between the smart coil and the vasospasm was not specified.As of (b)(6) 2021, the patient is stable.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed the device was advanced from its starting position within the introducer sheath and had offset coil winds on the embolization coil; therefore, the reported inability to advance the coil from its starting position could not be confirmed.If the introducer sheath is not aligned properly within the hub of a parent microcatheter prior to advancement, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the offset coil winds.During functional testing, the smart coil was re-sheathed to its starting position within its introducer sheath.The smart coil was then advanced through the introducer sheath with resistance due to the offset coil winds.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the reported complaint.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: 12131983
• Report Number: 3005168196-2021-01487
• Device Sequence Number: 3592804
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• 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): 08/16/2021
• 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: 06/01/2025
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F98174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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