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

Catalog Number	400SMTHXSFT1H04
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	08/09/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the coronary artery using penumbra smart coils (smart coils).During the procedure, the physician successfully implanted five smart coils into the target location.Upon advancement of the sixth smart coil through its introducer sheath, the physician experienced resistance and reported that the smart coil became stuck in the middle of its introducer sheath.Therefore, the smart coil was removed and was not used in the procedure.The procedure was completed using another smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was bent at approximately 132.5 cm and 135.0 cm from the proximal end, just proximal to the proximal end of the introducer sheath.The proximal end of the embolization coil had offset coil winds.The embolization coil was intact with the pusher assembly.During functional testing, resistance was experienced while attempting to advance the smart coil within its introducer sheath and the coil would only advance a few centimeters before the embolization coil would snake and become stuck within the introducer sheath.Conclusions: evaluation of the 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 catheter, resistance may be experienced during advancement and damage such as offset coil winds may occur.Further evaluation revealed pusher assembly bends.The bends on the pusher assembly were just proximal to the introducer sheath and were likely a result of handling when advancing the pusher assembly against resistance.The bends in the pusher assembly are incidental to the reported complaint.Penumbra devices 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9123865
• Report Number: 3005168196-2019-01825
• Device Sequence Number: 2537960
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• 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): 08/29/2019
• 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: 10/18/2022
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F80062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005