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

Catalog Number	400SMTXSFT0203
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and the coil winds were offset.Conclusions: evaluation of the returned smart coil revealed that the coil winds were offset.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, damage such as this may occur.While advancing the smart coil through a demonstration microcatheter, resistance was encountered as the coil entered the proximal shaft of the microcatheter and the smart coil could not be advanced any further.The offset coil winds may have contributed to the smart coil becoming stuck inside the hub of the microcatheter.The non-penumbra microcatheter 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left vertebral artery-posterior inferior cerebellar artery (va-pica) using penumbra smart coils (smart coils).During the procedure, the physician placed a non-penumbra coil and two smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil out of its introducer sheath and into the microcatheter, the coil became stuck at the hub of the microcatheter; therefore, it was 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: 7474144
• Report Number: 3005168196-2018-00901
• Device Sequence Number: 113560
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• 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): 04/03/2018

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: 01/30/2022
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F74094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1