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

Catalog Number 400SMTHXSFT0102

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00898.

Event Description

The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistulas (d-avf) using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached three smart coils in the peripheral branch of the occipital artery using a non-penumbra microcatheter.While attempting to advance a new smart coil into the microcatheter, the smart coil became stuck at the hub of the microcatheter; therefore, it was removed.The physician then attempted to advance another smart coil into the microcatheter; however, the smart coil also became stuck at hub of the microcatheter.Therefore, it was removed and the procedure was completed using a new smart coil, other coils and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly for the first smart coil evaluated.The pusher assembly was kinked approximately 136.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.The smart coil pusher assembly could not be advanced through its introducer sheath.Therefore, the smart coil could not be functionally tested through a demonstration microcatheter.Conclusions: evaluation of the smart coil revealed that the pusher assembly could not be advanced through the introducer sheath.During the functional test, resistance was encountered as the kink in the pusher assembly was attempted to advance through its introducer sheath; however, the smart coil could not be advanced.The kink likely occurred due to forceful advancement against resistance.The root cause of the initial resistance could not be determined.Evaluation of the smart coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as offset coil winds may occur.During the functional test, resistance was experienced as the embolization coil entered the hub of the microcatheter and the coil began to take shape inside the hub.The smart coil could not be advanced any further.If the embolization coil winds become offset, it is likely they can contribute to the inability to advance the coil past the hub of the microcatheter during the procedure and functional testing.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.

• 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: 7474053
• MDR Text Key: 106969914
• Report Number: 3005168196-2018-00897
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• 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: 05/03/2018
• 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: 08/01/2018
• 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