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

Model Number	4006U0201
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ophthalmic artery using penumbra coil 400s (pc400).During the procedure, the physician first placed a neuron max 6f 088 long sheath (neuron max) and advanced a px slim delivery microcatheter (px slim).The physician successfully implanted two pc400 in the aneurysm.After advancing the third pc400 through the px slim, the physician attempted to retract the pc400 in order to reposition it.However, while retracting the pc400, it unintentionally detached from the pusher assembly in the patient's body and occluded the m3 segment of the middle cerebral artery.The physician used a snare device to successfully retrieve the detached coil.The procedure was ended at this point and there was no report of an adverse effect to the patient.It should be noted that the physician used a rotating hemostasis valve (rhv) and maintained continuous flush throughout the procedure.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The embolization coil was detached from the pusher assembly and the stretch resistant (sr) wire was fractured.Conclusion: evaluation of the returned devices revealed the pc400 sr wire was fractured.Sr wire fracture typically occurs due to forceful retraction of the pc400 against resistance, and will allow the embolization coil to detach from the pusher assembly.Further evaluation revealed the px slim was slightly bent in the distal shaft.This damage was likely incidental, and did not cause resistance when advancing a 0.025¿ mandrel through the px slim.The neuron max mentioned in the complaint, as well as the pc400 embolization coil and introducer sheath, were not returned for evaluation.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #03 mfr report:3005168196-2016-01494.1.Section d.Box 4.Expiration date.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6038539
• Report Number: 3005168196-2016-01494
• Device Sequence Number: 18942944
• Product Code: HCG
• UDI-Device Identifier: 00814548011349
• UDI-Public: 00814548011349
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2016
• 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: 02/28/2018
• Device Model Number: 4006U0201
• Device Catalogue Number: 4006U0201
• Device Lot Number: A32870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 01/14/2005
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 12/29/2016; 05/12/2017; 03/12/2020
• 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: Required Intervention
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005