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

Catalog Number	400SMTSTD1660
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 in the splenic artery using penumbra smart coils (smart coils).During the procedure, the physician successfully placed a smart coil and an additional coil using a lantern delivery microcatheter (lantern).The physician then felt resistance while attempting to advance another smart coil out of the tip of the lantern, and therefore the smart coil was removed.The procedure was then completed using new smart coils, additional coils, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was kinked throughout its length, the introducer sheath was re-loaded backwards on the pusher assembly, and the embolization coil was intact with the pusher assembly.Conclusions: the smart coil instructions for use indicate that the penumbra smart coil system is compatible with microcatheters with a minimum inner diameter of 0.0165¿.The lantern has an inner diameter of 0.025¿.The use of a non-compatible microcatheter likely contributed to the reported issue.The damage observed throughout the smart coil was likely incidental to the reported issue, and likely occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7204450
• Report Number: 3005168196-2018-00177
• Device Sequence Number: 1133555
• Product Code: HCG
• UDI-Device Identifier: 00814548014326
• UDI-Public: 00814548014326
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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: 04/09/2022
• Device Catalogue Number: 400SMTSTD1660
• Device Lot Number: F75532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1