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

Catalog Number	400SMTXSFT0104
Medical Device Problem Codes	Failure to Advance (2524); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2017
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, a smart coil was re-sheathed after being advanced into the microcatheter.Later in the procedure, while attempting to re-advance the smart coil into the microcatheter, the physician was unable to advance the coil out of its introducer sheath.Therefore, the smart coil was removed and the procedure was completed using additional smart coils.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 144.0 cm from the proximal end.The introducer sheath was kinked on its distal end and the pusher assembly mid-joint was withdrawn proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly, was compressed distally, and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed a clear hardened substance occluded the distal end of the introducer sheath.The occlusion of the distal end of the introducer sheath likely contributed to the inability to re-advance the smart coil during the procedure, and initially prevented the smart coil from being re-sheathed during functional analysis.Further evaluation revealed the embolization coil was compressed distally, had offset coil winds, and the pusher assembly was kinked.This damage likely occurred due to forceful advancement and withdrawal of the smart coil against resistance.The damage observed on the embolization coil prevented the smart coil from being advanced after the occluded distal end of the smart coil was cut off.Further evaluation revealed the introducer sheath was kinked on its distal end.This damage may have occurred due to forceful manipulation during insertion or re-sheathing.Further evaluation revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the coil.The microcatheter mentioned in the complaint was not returned for evaluation.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: 6507735
• Report Number: 3005168196-2017-00613
• Device Sequence Number: 1268509
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2017

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: 10/18/2021
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F72373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1