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

Catalog Number	4006C0410
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2017
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 using penumbra coil 400s (pc400s).During the procedure, a pc400 unintentionally detached after advancing through the px slim delivery microcatheter (px slim).The physician was able to retrieve the coil using a non-penumbra stent retriever, and then completed the procedure using the same px slim and addition pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the penumbra coil 400 (pc400) was kinked approximately 5.0 cm from the proximal end.The pusher assembly was bent in multiple locations along its length.The proximal constraint sphere was located inside the distal detachment tip (ddt) and the fractured stretch resistant wire (sr wire) can be seen protruding from the coil winds.The pull wire was not retracted from the ddt and blood was clotted inside the ddt.The embolization coil was damaged along its length.Conclusion: evaluation of the device revealed the pc400 sr wire was fractured and the embolization coil was detached.Sr wire fracture may occur if the embolization coil is forcefully retracted against resistance, and will allow the embolization coil to detach from the pusher assembly.Further evaluation revealed several mild bends and a kink along the length of the pusher assembly.This damage is likely incidental and may have occurred during packaging for return to penumbra facilities.The px slim used throughout the procedure, as well as a penumbra coil 400 detachment handle that was not mentioned in the complaint, were returned and evaluated, and functioned as intended.Penumbra coils, catheters, and handles 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6295005
• Report Number: 3005168196-2017-00135
• Device Sequence Number: 30812
• Product Code: HCG
• UDI-Device Identifier: 00814548011912
• UDI-Public: 00814548011912
• 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): 01/04/2017

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: 12/26/2023
• Device Catalogue Number: 4006C0410
• Device Lot Number: F67077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 03/15/2017
• 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: 62 YR