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

Catalog Number	400SMTSFT3H06
Medical Device Problem Codes	Looping (1370); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
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 using penumbra smart coils (smart coils).During the procedure, the physician tested the smart coil in a tray of saline before attempting to advance it into the hub of the non-penumbra microcatheter.The physician then felt resistance after the smart coil formed a loop while advancing out of the tip of the introducer sheath and into the hub of the non-penumbra microcatheter, and therefore the smart coil was removed.The procedure was then completed using a new smart coil and additional coils with 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 in multiple locations.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned device revealed that the penumbra smart coil (smart coil) pusher assembly was kinked.These kinks were likely incidental and may have occurred from packaging the device for return to penumbra.The smart coil was attempted to be advanced through a demonstration microcatheter.While advancing the smart coil through the demonstration microcatheter, resistance was encountered as the kinks in the pusher assembly were being advanced through the microcatheter.However, the smart coil was able to be advanced completely through the microcatheter and out of the distal tip with the experienced resistance.The root cause of the reported resistance felt during the procedure and the reported looping of the smart coil could not be determined.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.Penumbra catheters and coils are inspected during in-process inspection and during quality inspection after manufacturing.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7204440
• Report Number: 3005168196-2018-00175
• Device Sequence Number: 16427444
• Product Code: HCG
• UDI-Device Identifier: 00814548017006
• UDI-Public: 00814548017006
• 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,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: 12/04/2021
• Device Catalogue Number: 400SMTSFT3H06
• Device Lot Number: F73015
• 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: 02/22/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR