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

Catalog Number	4004C0513
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
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: 3005168196-2018-00662.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400's (pc400's).During the procedure, the physician successfully placed four pc400's using a px slim delivery microcatheter (px slim).The physician then felt resistance and was unable to advance another pc400 past the middle of the px slim, and therefore the physician retracted the pc400.Upon removal of the pusher assembly, the physician found that the pc400 had unintentionally detached within the px slim, and therefore the px slim was removed with the pc400 inside.It was noticed that the px slim was slightly kinked, and the procedure was therefore completed using a new microcatheter and additional coils.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 in multiple locations.The embolization coil was detached from its pusher assembly with the pull wire still loaded in the distal detachment tip (ddt).The proximal constraint sphere was present on the proximal end of the embolization coil.The outer diameter (od) of the proximal constraint sphere and the inner diameter (id) of the ddt were measured and found to be within specification.Conclusions: evaluation of the returned pc400 revealed that the pet lock was intact on the proximal end of the pusher assembly and the embolization coil was detached.If the device is forcefully retracted against resistance, the pusher assembly polymer section may elongate beyond the reach and the pull wire, and likely result in the embolization coil detaching from its pusher assembly.Evaluation of the returned px slim revealed that the catheter was kinked.If the device was bent at an extreme angle or otherwise forcefully manipulated during use, damage such as a kink may occur.This kink likely contributed to the reported resistance during the procedure and subsequent detachment of the embolization coil the od of the proximal constraint sphere and the id of the ddt were measured and found to be within specification.After using a stainless-steel mandrel to push the subject pc400 out of the catheter, a demonstration coil encountered resistance when advanced through the px slim and out of the distal tip.Penumbra coil 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.This report is associated with mfr report number: 3005168196-2018-00662.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7385088
• Report Number: 3005168196-2018-00661
• Device Sequence Number: 1160376
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/15/2025
• Device Catalogue Number: 4004C0513
• Device Lot Number: F80601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005