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

Catalog Number	4006C0306
Medical Device Problem Codes	Break (1069); Inadequacy of Device Shape and/or Size (1583); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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: 3005168196-2018-00995.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra coils 400 (pc400¿s) and a px slim delivery microcatheter (px slim).During the procedure, the physician experienced resistance while advancing the last pc400 through the px slim.After advancing part of the pc400 into the aneurysm, the physician determined that the coil was too long and decided to remove it.However, while retracting the pc400 into the px slim, the physician experienced resistance and subsequently, the pc400 broke in two pieces and approximately three centimeters of the coil¿s tail went down into the posterior cerebral artery (pca).The rest of the pc400 was removed with its pusher assembly and the procedure was ended at that point as the physician did not have a snare device to remove the part of the coil that was protruding in the pca.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 31.0, 71.0 and 90.0 cm from the proximal end.The embolization coil was detached from its pusher assembly.The pc400 embolization coil was detached from its pusher assembly and, therefore, the pc400 could not be functionally tested through the returned px slim or a demonstration microcatheter.Conclusions: evaluation of the px slim revealed that the catheter was bent along its length.If the px slim was advanced through a tortuous anatomy, damage such as these bends may occur.Further evaluation of the returned px slim revealed resistance while advancing a stainless steel mandrel through the bends of the catheter and upon removal.However, a demonstration coil was advanced through the returned px slim and out of the distal tip without an issue.Evaluation of pc400 revealed that the embolization coil was detached from its pusher assembly and the pet lock was still intact.This type of damage likely occurs if the device is forcefully retracted against resistance, the pusher assembly may elongate enough so that the pull wire will retract from the ddt effectively detaching the coil.The embolization coil was not returned for evaluation.Further evaluation of the pc400 revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return to penumbra.Penumbra coils and catheters 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7527555
• Report Number: 3005168196-2018-00994
• Device Sequence Number: 11068827
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/19/2024
• Device Catalogue Number: 4006C0306
• Device Lot Number: F70227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 127
• Date Report Sent to FDA: 01/01/2005