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

Catalog Number	400SMTSTD0930
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	12/12/2017
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 kinked approximately 24.0, 27.0, 31.0, and 139.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed it could be advanced through a demonstration microcatheter without issue.Further evaluation revealed the pusher assembly had multiple kinks, with three kinks in close proximity near the proximal end.This damage may have occurred due to forceful advancement of the smart coil against resistance.Tortuous patient anatomy may have contributed to any resistance experienced during advancement of the smart coil.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 middle cerebral artery (mca) using penumbra smart coils (smart coils).It was noted that the patient anatomy was tortuous.During the procedure, while attempting to advance a smart coil through a non-penumbra microcatheter, the physician experienced resistance after advancing the smart coil approximately three quarters into the aneurysm and subsequently, the smart coil would not advance further; therefore, it was removed.The procedure was completed using another smart coil and the same microcatheter with no further issues.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: 7178664
• Report Number: 3005168196-2018-00098
• Device Sequence Number: 18862541
• Product Code: HCG
• UDI-Device Identifier: 00814548014364
• UDI-Public: 00814548014364
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/12/2017

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: 02/23/2022
• Device Catalogue Number: 400SMTSTD0930
• Device Lot Number: C01436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR