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

Catalog Number	400SMTSFT0615
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was intact with its pusher assembly.The embolization coil was stretched the length of the introducer sheath protruding out of both ends and the proximal end of the introducer sheath was frayed.The pusher assembly was kinked along its length.The pe fibers are fractured.Conclusions: evaluation of the returned smart coil revealed it was significantly stretched.If the smart coil is forcefully retracted against resistance, the embolization coil may stretch and pe fiber fracture may occur.Further evaluation also revealed pusher assembly damage along its length.These damages are likely due to forceful manipulation while attempting to advance or retract the device against resistance.The proximal end of the introducer sheath was frayed.This damage is unlikely to have contributed to the embolization coil damage observed during investigation.The root cause of the initial resistance and introducer sheath damage could not be determined.No other devices associated with this complaint were returned for evaluation.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 coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil out of its introducer and into a non-penumbra microcatheter, the physician experienced resistance and attempted to pull the coil back into the introducer sheath.The physician then noticed that the smart coil introducer sheath was damaged which also caused damage to the embolization coil.Therefore, the smart coil was removed and the procedure was completed using another 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: 7343679
• Report Number: 3005168196-2018-00580
• Device Sequence Number: 19195798
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/15/2018

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: 06/12/2022
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F77660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR