MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C1040
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional 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 number: 3005168196-2019-00710.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician encountered resistance while advancing a pc400 past the hub of the lantern.While retracting the pc400, it was reported that it unintentionally detached within the hub of the lantern.The pc400 was then removed and was no longer used in the procedure.The physician then attempted to advance another pc400, and reported that the pc400 was unable to advance past the initial position within its introducer sheath.This pc400 was also removed and was no longer used in the procedure.The procedure was completed using four additional pc400 coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was damaged but intact at the proximal end of the pusher assembly.The pusher assembly was fractured approximately 4.5 cm from the proximal end.Kinks were present along the pusher assembly approximately 1.5 cm, 8.5 cm, 37.5 cm, 73.0 cm and 121.0 cm from the proximal end.Offset coil winds were present along the embolization coil.The coil was returned detached from the pusher assembly distal detachment tip (ddt) and was found within the introducer sheath.Conclusions: evaluation of the first returned pc400 revealed a fracture at the proximal end of the pusher assembly.It was reported that resistance was encountered while advancing the pc400 through the hub of a lantern and was subsequently retracted out.If the device is forcefully mishandled while advancing or retracting against resistance, the pusher assembly may fracture.If the pusher assembly fractures, the pull wire may become retracted causing the embolization coil to detach from the pusher assembly distal dip detachment (ddt).Based on the reported complaint, the root cause of the resistance experienced during the procedure could not be determined.Further evaluation revealed kinks on the pusher assembly and an embolization coil with offset coil winds.If the device is forcefully advanced against resistance, damages such as this may occur.Based on the reported complaint, some of these damages were likely incidental to the reported complaint and may have occurred post procedure or during packaging for return to penumbra.Evaluation of the second returned pc400 revealed that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.The inner diameter (id) of the introducer sheath friction lock is smaller than the rest of the introducer sheath which allows it to seat properly on the pusher assembly mid-joint.If the mid-joint is moved past the friction lock, resistance may be encountered while advancing.During functional testing, the pc400 was able to advance through the introducer sheath with minor resistance.The pc400 was also able to advance through a demonstration microcatheter with minor resistance.Further evaluation revealed pusher assembly kinks.These damages were likely incidental to the reported complaint.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 number: 3005168196-2019-00710.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8522418
• Report Number: 3005168196-2019-00709
• Device Sequence Number: 19324233
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 4002C1040
• Device Lot Number: F82623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 61
• Date Report Sent to FDA: 01/01/2005