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

Catalog Number 400SMTXSFT0306

Device Problems Inadequacy of Device Shape and/or Size (1583); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the embolization coil was detached from its pusher assembly.The smart coil was detached from its pusher assembly and, therefore, the smart coil could not be functionally tested.Conclusions: evaluation of the first returned smart coil revealed that the embolization coil was detached from its pusher assembly.The pusher assembly of this smart coil and the non-penumbra catheter identified in the complaint were not returned for evaluation.The root cause of the unintentional detachment could not be determined.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: 3005168196-2019-00039.

Event Description

The patient was undergoing a coil embolization procedure in the vertebral artery (va) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed a smart coil using a non-penumbra microcatheter.The physician then advanced a second smart coil, however retracted to remove it because the smart coil was of the incorrect size.While retracting, the smart coil unintentionally detached within the microcatheter.Therefore, the physician removed the microcatheter with the smart coil inside and flushed the coil out of the microcatheter.The same microcatheter was then re-inserted, and 10 additional smart coils were placed.The physician then felt resistance while advancing within the introducer sheath and was unable to advance another smart coil through the hub of the microcatheter.Therefore, the smart coil was removed, and it was noticed that the tip of the smart coil was bent, and the proximal end of the coil was elongated.The procedure was then completed using additional 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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8236474
• MDR Text Key: 132812598
• Report Number: 3005168196-2019-00038
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2021
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F70768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• 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