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

Catalog Number	400SMTHXSFT2H04
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 139.0 and kinked approximately 137.5 and 138.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned device revealed that the smart coil was fractured.This type of damage typically occurs if the device forcefully advanced against resistance and the device becomes kinked.Subsequently, if the kinked device is further manipulated during use, damage such as a fracture may occur.Due to the returned condition of the device, the root cause of resistance could not be determined.The device was unable to be functionally tested during evaluation.Penumbra coils are visually 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 to treat a ruptured basilar aneurysm using penumbra smart coils (smart coils).During the procedure, the physician placed three non-penumbra coils and two smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil into the hub of the microcatheter, the physician experienced resistance and the smart coil would not advance into the hub of the microcatheter; therefore, it was removed.The procedure was completed using other coils, 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 94502
• MDR Report Key: 7678691
• Report Number: 3005168196-2018-01356
• Device Sequence Number: 848719
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 400SMTHXSFT2H04
• Device Lot Number: F78352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR