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

Catalog Number	400SMTXSFT0102
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	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Bends were present throughout the length of the pusher assembly.The embolization coil was intact with the pusher assembly.Offset coil winds were present along the embolization coil.Conclusions: evaluation of the returned smart coil revealed offset coil winds.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, resistance may be experienced.Forceful advancement against this resistance may result in offset coil winds.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.During functional testing, the smart coil was unable to advance through the hub of a demonstration microcatheter due to the offset coil winds.Further evaluation revealed pusher assembly kinks.These kinks were 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right external carotid artery (eca) using penumbra smart coils (smart coils).During the procedure, the physician encountered resistance while advancing the smart coil through its introducer sheath and reported that the smart coil was unable to advance into the hub of the non-penumbra microcatheter.Therefore, the smart coil was removed.The procedure was completed using additional smart coils.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: 9347951
• Report Number: 3005168196-2019-02143
• Device Sequence Number: 234395
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• 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: 11/11/2023
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F86995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005