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

Catalog Number	400SMTSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly of the first penumbra smart coil (smart coil) evaluated.The pusher assembly was severely kinked approximately 137.5 cm from the proximal end.The pusher assembly was also kinked in multiple locations.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first smart coil revealed that the pusher assembly was severely kinked.This type of damage likely occurred due to forceful advancement against resistance.Further evaluation of the first returned smart coil revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred due to packaging the device for return to penumbra.The severe kink prevented the smart coil pusher assembly from being advanced within its introducer sheath during the functional test.The root cause of the initial resistance could not be determined.Evaluation of the second smart coil revealed that the embolization coil winds were offset.This type of damage typically occurred due to improper handling during use.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, damage such as this may occur.Further evaluation of the returned device revealed that the introducer sheath friction lock was bunched-up on the proximal end of the sheath.This type of damage likely occurred due to forceful gripping during advancement against resistance.The damage to the introducers sheath friction lock did not prevent the smart coil from being advanced and retracted within the sheath.The root cause of the smart coil not be able to be advanced within its introducer sheath could not be determined.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra for 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.This report is associated with mfr report number: 3005168196-2018-00674.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed a smart coil using a non-penumbra microcatheter.The physician then was unable to advance two smart coils within their introducer sheaths, and therefore the smart coils were removed.The procedure was completed using additional smart 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: 7392427
• Report Number: 3005168196-2018-00673
• Device Sequence Number: 16498078
• Product Code: HCG
• UDI-Device Identifier: 00814548015040
• UDI-Public: 00814548015040
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/06/2018

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: 05/14/2022
• Device Catalogue Number: 400SMTSFT0306
• Device Lot Number: F77095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR