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

Catalog Number	400SMTXSFT0408
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	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked approximately 142.0 and 143.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds near its proximal end.Conclusions: evaluation of the returned device revealed the embolization coil had offset coil winds near its proximal end.If the introducer sheath is not properly aligned in the hub prior to advancement, resistance may be experienced, and damage such as this may occur.The pusher assembly kinks likely occurred due to forceful advancement of the smart coil against this resistance.The non-penumbra microcatheter mentioned in the complaint was not 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 in the internal carotid-posterior communicating artery using penumbra smart coils (smart coils).During the procedure, the physician successfully placed two coils using a non-penumbra microcatheter.The physician then experienced resistance and was unable to advance a smart coil through the hub of the microcatheter, and therefore the smart coil was removed.The physician re-attempted to advance the same smart coil into the microcatheter, however the same resistance was felt again.The physician therefore removed the smart coil and completed the procedure using additional coils 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: 7358417
• Report Number: 3005168196-2018-00624
• Device Sequence Number: 709158
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 08/20/2022
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F78761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1