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

Catalog Number	400SMTHXSFT0408
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a ruptured anterior communicating artery (acom) aneurysm using penumbra smart coils (smart coils).During the procedure, the physician placed the initial coils in the target vessel using a non-penumbra microcatheter.The physician was then unable to advance a new smart coil out of its introducer sheath and into the microcatheter; therefore, it was removed.The procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 137.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the coil winds were offset.Conclusions: evaluation of the returned device revealed that the embolization coil winds were offset.This type of damage typically occurs 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.The offset coil winds likely prevented the smart coil from being advanced out of its introducer sheath and into the microcatheter during the procedure.While advancing the smart coil through a demonstration microcatheter; resistance was encountered as the offset coil winds entered the hub of the microcatheter and began to take shape.The smart coil could not be advanced any further.The smart coils introducer sheath was not returned for evaluation.The non-penumbra microcatheter referred to in the complaint was not returned 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7165872
• Report Number: 3005168196-2018-00038
• Device Sequence Number: 72915
• Product Code: HCG
• UDI-Device Identifier: 00814548015828
• UDI-Public: 00814548015828
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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,Followup
• Report Date (Section B): 12/07/2017

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: 06/18/2022
• Device Catalogue Number: 400SMTHXSFT0408
• Device Lot Number: F77752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR