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

Catalog Number 400SMTXSFT0410

Device Problems Kinked (1339); Failure to Advance (2524); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra smart coil (smart coil) pusher assembly was kinked approximately 136.0 cm from the proximal end.Conclusions: evaluation of the returned smart coil revealed that the device was kinked but able to be advanced through the demonstration microcatheter during functional analysis.There was minor resistance felt when the pusher assembly kink passed through the hub of the microcatheter.This kink was likely a result of forcefully advancing the device against resistance.The non-penumbra microcatheter mentioned in the compliant was not returned for evaluation.Therefore, the root cause of the physician¿s inability to advance the coil into the microcatheter during the procedure could not be determined.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.

Event Description

The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coils).During the procedure, the physician advanced a non-penumbra microcatheter towards the target vessel and then placed two coils.While attempting to advance a new smart coil out of its introducer sheath and into the microcatheter, the physician seated the introducer sheath onto the hub of the microcatheter via the rotating hemostasis valve (rhv) and attempted to advance the coil out; however, the smart coil did not advance out of its sheath.The physician then applied force to advance the coil and consequently, the smart coil pusher assembly became kinked.Therefore, the smart coil was removed and the procedure was successfully completed using a new smart coil, additional coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7176841
• MDR Text Key: 97733530
• Report Number: 3005168196-2018-00096
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F77669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1