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

Catalog Number	4006C0204
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400) with a px slim delivery microcatheter (px slim).During the procedure, while retracting a pc400 through the px slim, the pc400 unintentionally detached and, therefore, was removed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the pc400 pusher assembly.The pusher assembly was kinked approximately 142.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and the stretch resistant (sr) wire was fractured.There was no visible damage to the px slim.Conclusion: evaluation of the returned device revealed the pc400 sr wire was fractured.This type of damage typically occurs due to forceful manipulation of the pc400 during retraction.Further evaluation revealed the pc400 pusher assembly was kinked.This damage was likely incidental and may have occurred during packaging for return.The px slim had no visible damage and was 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5842853
• Report Number: 3005168196-2016-01133
• Device Sequence Number: 16293201
• Product Code: HCG
• UDI-Device Identifier: 00814548011783
• UDI-Public: 00814548011783
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2016

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: 12/13/2023
• Device Catalogue Number: 4006C0204
• Device Lot Number: F66953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR