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

Catalog Number	4002C0830
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2016
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).During the procedure, while advancing a pc400 through a px slim delivery microcatheter (px slim), the pc400 unintentionally detached within the px slim; therefore, it was removed.It was also reported that a pc400 pusher assembly was found bent while removing it from the packaging.There was no report of adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2016-00909.Result: the first penumbra coil 400 (pc400) embolization coil was detached from the pusher assembly and had the proximal constraint sphere intact.The outer diameter (od) of the proximal constraint sphere and embolization coil were measured and found to be within specification.The pet lock was intact on the proximal end of the second pc400¿s pusher assembly, and the pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusion: evaluation of the first pc400 revealed the embolization coil was detached from the pusher assembly and had the proximal constraint sphere intact.The ods of the proximal constraint sphere and embolization coil were measured and found to be within specification.Since the pusher assembly was not returned for evaluation, the root cause of the unintentional detachment could not be determined.Evaluation of the second pc400 revealed the pusher assembly was kinked.This damage may have occurred due to forceful manipulation of the pc400 at extreme angles during removal from the packaging.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils 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: 5761633
• Report Number: 3005168196-2016-00908
• Device Sequence Number: 13452950
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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
• Report Date (Section B): 05/31/2016

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: 11/13/2018
• Device Catalogue Number: 4002C0830
• Device Lot Number: A18837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 09/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR