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

Catalog Number	4006C0303
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please no the device was implanted in the patient; however, the device pusher assembly has been returned.Results: the proximal end of the pusher assembly was fractured approximately 162.5 cm from the distal tip (figure 1).The pusher assembly was kinked in multiple locations (figure 2).The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned devices revealed that the pc400 pusher assembly was fractured.This type of damage likely occurred due to an attempt to manually detach the pc400 embolization coil from its pusher assembly as mentioned in the complaint description.Tortuosity within the vessel will likely cause the pull wire to build up friction inside the hypotube of the pusher assembly, which the pull force of the handle may not be able to overcome.Once the pusher assembly is manipulated, friction inside the hypotube may be decreased and the embolization coil may detach from its pusher assembly.The excessive tortuosity within the entire ica likely contributed to the pc400 embolization coil not initially detaching from its pusher assembly.Evaluation of the px slim revealed that the catheter shaft was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated at extreme angles, damage such as this may occur.The kink in the px slim was likely unrelated to the pc400''s detachment issue as this damage was not mentioned in the complaint.Penumbra catheters and 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using a penumbra coil detachment handle (handle) and penumbra coil 400s (pc400s).During the procedure, the physician successfully placed a pc400 using the handle after advancing through a px slim delivery microcatheter (px slim).The physician then advanced the pc400 into the target location through the px slim and attempted to detach the pc400 using the same handle, however the pc400 did not detach, despite the black pet lock being separated.The physician therefore attempted to manually detach the coil by pulling on the nitinol wire, and then by breaking the hypotube to attempt to detach the coil, but was unsuccessful.The physician then flushed and jiggled the px slim and pull wire, eventually causing the pc400 to detach.The procedure was completed at this point as this was the last coil needed.It was reported that there was excessive tortuosity within the entire internal carotid artery (ica), from the low cervical all the way up to the bifurcation.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note the device was implanted in the patient; however, the device pusher assembly has been returned.Results: the proximal end of the pusher assembly was fractured approximately 162.5 cm from the distal tip.The pusher assembly was kinked in multiple locations.Conclusions: evaluation of the returned devices revealed that the pc400 pusher assembly was fractured.This type of damage likely occurred due to an attempt to manually detach the pc400 embolization coil from its pusher assembly as mentioned in the complaint description.Tortuosity within the vessel will likely cause the pull wire to build up friction inside the hypotube of the pusher assembly, which the pull force of the handle may not be able to overcome.Once the pusher assembly is manipulated, friction inside the hypotube may be decreased and the embolization coil may detach from its pusher assembly.The excessive tortuosity within the entire ica likely contributed to the pc400 embolization coil not initially detaching from its pusher assembly.The proximal fractured portion of the pusher assembly was not returned for evaluation.Evaluation of the px slim revealed that the catheter shaft was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated at extreme angles, damage such as this may occur.The kink in the px slim was likely unrelated to the pc400''s detachment issue as this damage was not mentioned in the complaint.The pc400 detachment handle identified in the complaint was not returned for evaluation.Penumbra catheters and 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.This report is associated with mfr report number: 3005168196-2018-00128.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7186717
• Report Number: 3005168196-2018-00127
• Device Sequence Number: 96516
• Product Code: HCG
• UDI-Device Identifier: 00814548011806
• UDI-Public: 00814548011806
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017
• 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: Physician
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 4006C0303
• Device Lot Number: A41359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005