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

Catalog Number	400SMTSFT0820
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the smart coil was kinked approximately 48.0, 49.0, 89.0, and 91.0 cm from the proximal end.The polymer section of the smart coil pusher assembly was kinked along its length.The distal detachment tip (ddt) was delaminated.There were offset coil winds on the embolization coil.Conclusions: evaluation of the returned smart coil revealed a few pusher assembly kinks and an extensively kinked polymer section.These damages were likely due to forceful advancement against resistance.Some additional kinks may have occurred incidentally during packaging for return to penumbra.The non-penumbra catheter was not returned and, therefore, the root cause of the initial resistance could not be determined.Further evaluation revealed a few offset coil winds and a slightly delaminated ddt.These damage were likely due to repeated manipulation in attempt to advance the embolization coil against the reported resistance.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 coils embolization procedure to treat a subarachnoid hemorrhage using penumbra smart coils (smart coils).During the procedure, the physician placed the initials coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician experienced resistance and the smart coil would not advance.Therefore, the physician let the flush run through the microcatheter and attempted to advance the smart coil again; however, resistance was encountered again and the physician removed the coil.The procedure was completed using a new smart coil and the same 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: 7162428
• Report Number: 3005168196-2018-00020
• Device Sequence Number: 1979001
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: No Information
• Device Expiration Date: 07/18/2021
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F70709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR