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

Catalog Number 4002C1040

Device Problems Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

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 number: 3005168196-2017-02221.

Event Description

The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400s (pc400s).During the procedure, the physician successfully deployed and detached a pc400 using a non-penumbra microcatheter.The physician then felt resistance while advancing another pc400 through the middle of the microcatheter and the pc400 became stuck and unable to advance; therefore, the microcatheter was removed with the pc400 inside.The physician then inserted a new non-penumbra microcatheter and successfully deployed and detached two pc400s.Next, the physician experienced resistance again while advancing another pc400 through the middle of the microcatheter, and the pc400 became stuck and unable to advance; therefore, the microcatheter was removed with the pc400 inside.The physician then removed the pc400 from the microcatheter and reinserted the same microcatheter.The procedure was then completed using additional pc400s and additional coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the first pc400¿s pusher assembly was fractured approximately 105.0 cm from distal end (figure 1).The pull wire was completely retracted out of the pusher assembly hypotube and the embolization coil was detached.Conclusions: evaluation of the returned devices revealed both pc400¿s embolization coils were detached.Due to the detached embolization coils, the pc400s could not be functionally tested for advancement through a microcatheter.However, upon attempting to advance a demonstration coil through the returned non-penumbra microcatheter, the coil could not be advanced through the fractured region of the microcatheter.If the non-penumbra microcatheter was damage during attempts to advance, this damage may have contributed to the reported resistance.Further evaluation revealed the second pc400¿s detached embolization coil had offset coil winds.This type of damage typically occurs due to forceful advancement against resistance.Further evaluation revealed the first pc400¿s pusher assembly was fractured and the second pc400¿s sr wire was fractured.Since only the distal segment of the first pc400¿s pusher assembly was returned, and since both pc400s were reportedly removed from the non-penumbra microcatheter with no mention of detachment, this damage was likely incidental to the reported issues.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: 3005168196-2017-02221.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow up report and is being corrected on this follow-up #02 mfr report: 1.Narrative/corrected data.Results: the first pc400¿s pusher assembly was fractured approximately 105.0 cm from distal end.The pull wire was completely retracted out of the pusher assembly hypotube and the embolization coil was detached.Conclusions: evaluation of the returned devices revealed both pc400¿s embolization coils were detached.Due to the detached embolization coils, the pc400s could not be functionally tested for advancement through a microcatheter.However, upon attempting to advance a demonstration coil through the returned non-penumbra microcatheter, the coil could not be advanced through the fractured region of the microcatheter.If the non-penumbra microcatheter was damage during attempts to advance, this damage may have contributed to the reported resistance.Further evaluation revealed the second pc400¿s detached embolization coil had offset coil winds.This type of damage typically occurs due to forceful advancement against resistance.Further evaluation revealed the first pc400¿s pusher assembly was fractured and the second pc400¿s sr wire was fractured.Since only the distal segment of the first pc400¿s pusher assembly was returned, and since both pc400s were reportedly removed from the non-penumbra microcatheter with no mention of detachment, this damage was likely incidental to the reported issues.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: 3005168196-2017-02221.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7129333
• MDR Text Key: 95910172
• Report Number: 3005168196-2017-02220
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 4002C1040
• Device Lot Number: F72831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR