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

Catalog Number	400SMTSFT4H10
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	02/22/2017
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.This report is associated with mfr report number: 3005168196-2017-00505.
Event or Problem Description
The patient was undergoing a coil embolization in the left posterior communicating artery using penumbra smart coils (smart coils).During the procedure, the physician placed another manufacturer¿s catheter and microcatheter in the target vessel then attempted to advance a smart coil through the microcatheter.However, resistance was experienced and the smart coil became stuck and unable to move further about 3-5mm from the detachment point.The physician then repositioned the microcatheter but the smart coil remained stuck; therefore, it was removed.The physician then attempted to advance another smart coil; however, the same failure event occurred and therefore, the smart coil was removed as well.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 second smart coil evaluated.The embolization coil was intact with its pusher assembly.The outer diameter (od) of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the first smart coil revealed that the embolization coil windings were offset.This type of damage typically occurs due to improper handling during use.If the introducer sheath is not properly seated inside the hub of the microcatheter prior to insertion, damage such as this may occur.During the functional analysis the smart coil could not be advanced through a demonstration microcatheter.The offset coil windings likely contributed to the resistance that was experienced and prevented the smart coil from advancing through a demonstration microcatheter during functional analysis.Evaluation of the second smart coil revealed that the device was functional.During the functional analysis of the smart coils was advanced through a demonstration microcatheter and out of the distal tip without an issue.The od of both embolization coils were measured and found to be within specification.The root cause of the resistance experienced while advancing the second evaluated smart coil could not be determined.Further evaluation of the returned devices revealed that the non-penumbra microcatheter distal tip was ovalized.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: 3005168196-2017-00505.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6443185
• Report Number: 3005168196-2017-00506
• Device Sequence Number: 18957866
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• 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): 03/03/2017

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: 04/28/2021
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F69145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 43