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

Catalog Number	400SMTSFT3H08
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) embolization coil was detached from its pusher assembly and, therefore, the smart coil was not functionally tested for detachment.Conclusions: evaluation of the returned device revealed the device is returned kinked and folded, and based on the returned condition of the smart coil, the root cause of the reported detachment issue could not be determined.If the device is returned kinked and folded, the penumbra investigator will not be able to determine the reported issue.Evaluation of the returned handle revealed that the handle was functional.The handle was functionally tested on the handle fixture for pull force, throw distance, and passed both specifications without an issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% functionally tested during incoming inspection by quality.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery-posterior communicating artery (ic-pc) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).It was noted that the patient anatomy was slightly tortuous.During the procedure, the physician advanced a smart coil through a non-penumbra microcatheter and attempted to detach it using the handle; however, the coil failed to detach.After four to five failed attempts, the physician bent the smart coil pusher assembly and pulled the pull wire; however, the smart coil did not detach.The physician then decided to retract the smart coil; however, the smart coil unintentionally detached in the microcatheter after being retracted approximately two centimeters back into the microcatheter.Therefore, the physician used the coil''s pusher assembly to push the detached coil into the aneurysm.The procedure was completed 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: 7200221
• Report Number: 3005168196-2018-00154
• Device Sequence Number: 1043251
• Product Code: HCG
• UDI-Device Identifier: 00814548017013
• UDI-Public: 00814548017013
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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: Physician
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: 400SMTSFT3H08
• Device Lot Number: F73016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR