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

Catalog Number	400SMTSFT0408
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
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 using penumbra smart coils (smart coils).During the procedure, the physician successfully placed a coil using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance a smart coil within its introducer sheath.The physician attempted to slightly retract and re-advance the smart coil, however, the smart coil was stuck.The smart coil was, therefore, removed, and the procedure was completed using a new smart coil and additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly had bends approximately 14.0 cm, 28.0 cm, and 121.0 cm from the proximal end of the pusher.The pusher was kinked approximately 63.5 cm from the proximal end of the pusher assembly.The pusher was fractured approximately 137.0 cm from the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was detached from the distal detachment tip (ddt) for the pusher assembly.Conclusions: evaluation of the returned smart coil revealed a fractured pusher assembly and a pusher assembly mid-joint retracted through the introducer sheath friction lock.The inner diameter (id) of the introducer sheath friction lock is smaller than the id of the rest of the sheath so that it seats on the mid-joint snugly.If the mid-joint is retracted through the friction lock past where it is designed to seat, resistance may be experienced when attempting to advance the device.If the device is forcefully advanced and retracted while experiencing resistance, damage such as bends, kinks, and fracture may occur.Further evaluation revealed the embolization coil detached from the distal detachment tip (ddt).If the pusher assembly fractures, this will likely cause the pull wire to retract from the ddt and detach the embolization coil.Based on the return condition, some of the kinks and bends are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7848748
• Report Number: 3005168196-2018-01743
• Device Sequence Number: 13739075
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• 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): 08/08/2018
• 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: 06/20/2022
• Device Catalogue Number: 400SMTSFT0408
• Device Lot Number: F77825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005