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

Model Number	4002C2060
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	01/13/2020
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2020-00164.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and microcatheter.During the procedure, while advancing the pc400 through the microcatheter the physician experienced resistance and decided to retract the pc400.However upon retraction, the pc400 had unintentionally detached inside the microcatheter.Therefore, the physician removed the microcatheter containing the detached pc400 and then removed the pc400.The physician then reinserted the same microcatheter and attempted to advance another pc400; however, the same issue occurred, and the pc400 unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pc 400 was removed.The procedure was completed using additional pc400s and a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 02/07/2020: results: the proximal portion of the pusher assembly with the pet lock was fractured off and not returned for evaluation.The length of the returned fractured pusher assembly was measured approximately 152.0 cm.The pusher assembly was kinked approximately 37.0 cm, 42.0 cm and 90.0 cm from its proximal end.The pull wire was retracted from the distal detachment tip (ddt) and not returned for evaluation.The embolization coil was detached, and proximal constraint sphere was intact with the embolization coil.The distal portion of the embolization coil approximately 16.0 cm was hanging outside of the distal tip of the introducer sheath.A stretch resistance wire (sr wire) fracture near the distal end of the embolization coil and offset coil winds were observed on the distal portion of embolization coil.Conclusions: evaluation of the returned pc400 revealed that the pull wire was retracted from the distal detachment tip (ddt), the embolization coil was detached from the pusher assembly, and the embolization coil sr wire was fractured.If the pusher assembly fractures, the pull wire can become retracted from ddt detaching the embolization.Additionally, if the embolization coil is retracted against resistance, the sr wire can become fractured detaching the embolization coil.Due to the return damage on the device, the cause of the reported detachment was unable to be determined.Further evaluation of the device revealed that the pusher assembly was kinked, and the embolization coil had offset coil winds.These damages were likely incidental to the complaint.The proximal portion of the fractured pusher assembly with the pet lock, the pull wire and the px slim used in the procedure were not returned for evaluation.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return damage on the device.This report is associated with mfr report numbers: 1.3005168196-2020-00164, 2.3005168196-2020-00264.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra coil 400s (pc400s) and px slim delivery microcatheter (px slim).During the procedure, while advancing the pc400 through the px slim the physician experienced resistance and decided to retract the pc400.However, upon retraction, the pc400 had unintentionally detached inside the px slim.Therefore, the physician removed the px slim containing the detached pc400 and then flushed out the pc400.The physician then reinserted the same microcatheter and attempted to advance another pc400; however, the same issue occurred, and the pc400 unintentionally detached inside the px slim.Therefore, the px slim containing the detached pc 400 was removed.The procedure was completed using additional pc400s and a new px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9682956
• Report Number: 3005168196-2020-00165
• Device Sequence Number: 3445167
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 01/17/2020
• 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 Model Number: 4002C2060
• Device Catalogue Number: 4002C2060
• Device Lot Number: F90312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 09/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005