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

Catalog Number 400SMTHXSFT0103

Device Problems Device Difficult to Setup or Prepare (1487); Out-Of-Box Failure (2311); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra smart coil (smart coil) pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Blood was observed inside the introducer sheath and on the embolization coil.During functional analysis, the blood was flushed out of the introducer sheath by a penumbra investigator.The smart coil could then be advanced out of the introducer sheath with mild resistance.Conclusions: evaluation of the returned device revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced by the physician upon attempting to advance the smart coil.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 using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached three coils into the aneurysm.While preparing a new smart coil for the procedure, the scrub technologist was unable to advance the smart coil out of its introducer sheath and into heparinized saline.The physician then attempted to advance the smart coil out of its introducer sheath but was also unable to do so.Therefore, the smart coil was not used for the procedure and did not enter the patient's body.The procedure was completed using a new smart coil.It was reported that the friction lock felt as if it was clamped down on the smart coil pusher assembly.

• 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: 6432206
• MDR Text Key: 70908730
• Report Number: 3005168196-2017-00456
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2021
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F72537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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