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

Catalog Number 400SMTHXSFT0208

Device Problems Collapse (1099); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2019-00313; 3005168196-2019-00315.

Event Description

The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed six smart coils into the target vessel using a non-penumbra microcatheter.The physician then felt resistance while advancing the seventh smart coil through the hub of the microcatheter and was unable to advance it any further.The smart coil was removed and was not used in the procedure.The physician then felt resistance while advancing the eighth smart coil through the hub and the same issue occurred.This smart coil was also removed.The physician then successfully placed five additional smart coils into the target vessel using the same microcatheter.Upon advancement of the twelfth smart coil through the hub of the microcatheter, the physician again felt resistance and the same issue occurred.The twelfth smart coil was therefore removed.The procedure was completed using five additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.Additionally, it was noted that the tips of the three complaint smart coils appeared to be crushed.

Manufacturer Narrative

Results: the pet locks for the devices were intact at the proximal ends of their pusher assembly.Bends and kinks were present along the length of the pusher assemblies.The embolization coils were intact with the pusher assembly distal detachment tips (ddt).Offset coil winds were present along the length of the coils.Conclusions: evaluation of the returned smart coils revealed all three embolization coils had offset coil winds.If the introducer sheaths are not seated properly within the hub of the parent catheter, resistance may be encountered while advancing.If the device is advanced against this resistance, offset coil winds will likely occur.This damage likely contributed to the reported inability to advance the coils.During functional testing, the first and third smart coils were re-sheathed but were unable to advance out of their introducer sheaths due to the offset coil winds.The second smart coil was too damaged and was unable to be functionally tested.Further evaluation revealed pusher assembly and additional embolization coil damages.Based on the returned condition, these damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report numbers: 3005168196-2019-00313 and 3005168196-2019-00315.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8360290
• MDR Text Key: 136846329
• Report Number: 3005168196-2019-00314
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Catalogue Number: 400SMTHXSFT0208
• Device Lot Number: F78839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• 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: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1