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

Catalog Number	400SMTSTD0620
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
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 had offset coil winds.Conclusions: evaluation of the first evaluated smart coil revealed that the embolization 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 embolization coil began to take shape inside the hub of the microcatheter.The smart coil could not be advanced any further.Evaluation of the second evaluated smart coil revealed that the embolization coil winds were offset and the smart coil was able to be advanced through the microcatheter.If the introducer sheath is not properly aligned inside the hub of the microcatheter prior to advancement, damage such as offset coil winds may occur.The smart coil was able to be advanced completely through the demonstration catheter and out of the distal tip without an issue.These offset coil winds likely contributed to the reported resistance.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.This report is associated with mfr report number: 3005168196-2018-01293.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil into an access sheath, the physician experienced resistance and the smart coil became stuck at the distal tip of its introducer sheath and would not enter the access sheath; therefore, it was removed.It was reported that the same issue occurred with another smart coil.The procedure was completed using additional coils and the same access sheath.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: 7652776
• Report Number: 3005168196-2018-01294
• Device Sequence Number: 1652423
• Product Code: HCG
• UDI-Device Identifier: 00814548014678
• UDI-Public: 00814548014678
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/31/2018

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: 01/02/2021
• Device Catalogue Number: 400SMTSTD0620
• Device Lot Number: F67153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1