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

Catalog Number	400SMTHXSFT0420
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet locks on the proximal end of the penumbra smart coil (smart coil) pusher assemblies were intact.The embolization coils were intact with their pusher assemblies.The embolization coils were slightly damaged and had offset coil winds.The embolization coil of the second smart coil evaluated was severely damaged near the distal end of the coil.The introducer sheath inner diameters (ids) were measured to be within specification.The embolization coil outer diameters (ods) were measured to be within specification.The smart coils were cycled through their respective introducer sheaths, and resistance was encountered.A demonstration introducer sheath was used, but resistance was again encountered.Conclusions: evaluation of the returned devices revealed that both smart coils met resistance during functional analysis.The introducer sheath ids and the embolization coil ods were measured to be within specification.Further evaluation revealed that both embolization coils were damaged and had offset coil winds.This damage may have occurred due to forceful advancement of the smart coils against resistance.The root cause of the initial resistance experienced when trying to advance the smart coils 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 number: 3005168196-2017-00093.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, while attempting to advance two smart coils out of their introducer sheaths and into a non-penumbra microcatheter, the physician encountered resistance and subsequently, both coils became stuck inside their introducer sheaths.Therefore, the physician removed both of the smart coils and completed the procedure using a non-penumbra coil and the same non-penumbra microcatheter.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: 6265578
• Report Number: 3005168196-2017-00092
• Device Sequence Number: 1027251
• Product Code: HCG
• UDI-Device Identifier: 00814548017334
• UDI-Public: 00814548017334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/22/2016

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: 11/06/2021
• Device Catalogue Number: 400SMTHXSFT0420
• Device Lot Number: F72655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR