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

Catalog Number	4004J25
Medical Device Problem Codes	Physical Resistance (2578); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2016
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: 3005168196-2016-01849.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (p-com) using penumbra coils 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician deployed a pc400 into the target vessel using the px slim; however, due to strong friction in the px slim, the pc400 failed to detach.Therefore, the px slim and pc400 were removed and the procedure was completed using another manufacturer¿s coils and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pc400 was inside the px slim, and damaged in multiple locations (figure 1).The pet lock on the proximal end of the pc400 pusher assembly was intact (figure 2).The pusher assembly was fractured approximately 37.5 cm from the proximal end, and kinked in multiple locations (figure 3).The coil was detached from the pusher assembly, and the proximal constrain sphere was intact with the coil (figure 4).The embolization coil was damaged and had offset coil windings.Conclusions: evaluation of the returned devices revealed that the pc400 pusher assembly was kinked and fractured, and the embolization coil was detached.This damage was likely incidental, and may have occurred due to forceful handling of the pc400 during packaging for return to penumbra.If the pusher assembly becomes fractured, it may allow the pull wire to withdraw out of the distal detachment tip (ddt), which will cause the embolization coil to detach.Further evaluation revealed the embolization coil had offset windings in multiple locations.This damage may have occurred due to forceful manipulation of the pc400 at extreme angles during advancement or retraction and may have contributed to the friction experience by the physician.Due to the return condition of the pc400, penumbra investigators were unable to determine the difficulty detaching the coil.A 0.025¿ mandrel was inserted through the hub of the px slim and advanced out the distal tip without issue.The px slim was, therefore, functional.Penumbra coils and catheters 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: 3005168196-2016-01849.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6186412
• Report Number: 3005168196-2016-01848
• Device Sequence Number: 970697
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

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: 11/10/2023
• Device Catalogue Number: 4004J25
• Device Lot Number: F66472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/09/2017
• 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