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

Catalog Number 400SMTXSFT0306

Device Problems Knotted (1340); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly and knotted in two locations.The embolization coil had dried blood on it.The smart coil¿s embolization coil was knotted in two locations and the pusher assembly was kinked.Therefore, the smart coil could not be functionally tested through a demonstration microcatheter.Conclusions: evaluation of the returned device confirmed that the smart coil was knotted in two locations.However, the root cause of the smart coil being knotted could not be determined.Further evaluation of the returned device revealed that the embolization coil had dried blood on it.The complaint stated that the device was not used in the procedure and, therefore, the root cause of the dried blood on the embolization coil could not be determined.Further evaluation of the returned device revealed that the smart coil pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occur while packaging the device for return to penumbra.The smart coil's introducer sheath was not returned for evaluation.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.

Event Description

While preparing a new penumbra smart coil (smart coil) for a coil embolization procedure, the hospital staff noticed that the coil was knotted upon removal from the packaging hoop.The damaged smart coil was found prior to use and therefore, was not used in the procedure.The procedure was completed using an additional coil.

• 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: 7149436
• MDR Text Key: 96234880
• Report Number: 3005168196-2017-02292
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F68280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• 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