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

Catalog Number 400SMTHXSFT0102

Device Problems Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pusher assembly was retracted so that the pusher mid-joint was stuck inside the introducer sheath friction lock.The pusher assembly was kinked along its proximal length and just proximal to the introducer sheath conclusions: evaluation of the returned smart coil revealed the pusher was retracted such that it became stuck inside the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath,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the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced upon attempting to advance the coil.Further evaluation revealed kinks along the proximal pusher assembly and just proximal to the introducer sheath.The distal kink was likely a result of forcefully gripping and advancing the coil against resistance.The other kinks were likely due to packaging for return to penumbra.Additional kinks were created by the penumbra investigator during functional analysis also.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 internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached eight smart coils using a non-penumbra microcatheter.The physician then felt resistance advancing another smart coil out of its introducer sheath and into the hub of the microcatheter.The hospital staff attempted to forcefully advance the smart coil, and consequently the pusher wire of the smart coil became kinked.The smart coil was therefore removed, and the procedure was then completed using two new smart 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7261711
• MDR Text Key: 99889856
• Report Number: 3005168196-2018-00310
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• 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
• Type of Report: Initial
• Report Date: 01/18/2018

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
• Device Operator: Physician
• Device Expiration Date: 06/22/2022
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F77864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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