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

Catalog Number	400SMTSTD0725
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The embolization coil is implanted in the patient; however, the pusher assembly is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2017-00319, 3005168196-2017-00320.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician placed another manufacturer¿s microcatheter and an intracranial stent device to cover the neck of cavernous aneurysm in the target vessel, and then initiated the coil embolization using a jailing technique.While attempting to advance a smart coil through the microcatheter, the physician had difficulty right before the coil pusher assembly was inside the microcatheter.Although the smart coil introducer sheath was removed from the proximal portion of the pusher assembly, the physician still experienced difficulty advancing the smart coil.However, the physician eventually advanced the smart coil into the microcatheter but the smart coil was removed because it small.The physician then opened a new smart coil.Although the physician noted that it was also difficult to advance the new smart coil through the microcatheter like the previous smart coil; the physician was able to advance and implant it into the aneurysm.The physician then successfully re-advanced and implanted the first smart coil that was removed due to the sizing issue.After that, another manufacturer¿s coil was deployed and detached into the aneurysm.It reported that the physician also had difficulty while advancing a new smart coil through the microcatheter; however, the smart coil was advanced and implanted into the aneurysm.The procedure was continued using three coils from other manufacturers and the same microcatheter.The physician reported experiencing difficulty while advancing two of the last three coils from the other manufacturers through the microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the smart coil pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from the pusher assembly.There was no visible damage to the smart coil introducer sheath.The outer diameter (od) of the pusher assembly and distal detachment tip (ddt) were measured and found to be within specification.Conclusions: evaluation of the returned smart coil revealed the pet lock was broken and the embolization coil was detached.A broken pet lock indicates that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the embolization coil.Further evaluation revealed the pusher assembly was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.The ods of the pusher assembly and ddt were measured and found to be within specification.Since the embolization coil was successfully detached and the other two smart coils mentioned in the complaint were not returned for evaluation, the root cause of the difficulty advancing 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: 3005168196-2017-00319, 3005168196-2017-00320.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6387970
• Report Number: 3005168196-2017-00318
• Device Sequence Number: 18966992
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2017

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: Physician
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 400SMTSTD0725
• Device Lot Number: F71467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1