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

Catalog Number	4004J15
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2016
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 for a recurrent aneurysm using penumbra coil 400's (pc400's).During the procedure, the pc400 unintentionally detached; therefore, the pc400 was removed.The physician then completed the procedure using the same px slim and a new pc400.In addition, the physician reported using a rotating hemostasis valve and maintaining continuous flush.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 8.0 and 11.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.The embolization coil was damaged throughout its length.The embolization coil was unable to be re-sheathed.The outer diameter (od) of the proximal constraint sphere was measured to be within specification.Conclusion: evaluation of the device revealed the embolization coil was damaged along its length.If the introducer sheath is not properly seated in the taper of the px slim hub, the embolization coil may begin to take shape within the hub.If the embolization coil begins to take shape in the hub of the microcatheter, offset coil windings may occur as a result.The offset coil windings would likely make it increasingly difficult to advance the embolization coil into a microcatheter.Further evaluation revealed kinks in the pusher assembly.This damage is likely incidental and may have occurred during packaging for return to penumbra facilities.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.
Event or Problem Description
Despite several attempts made for additional information regarding the reported event, clarification was not provided until january 9, 2017 which stated that there was a mix up of cases and devices when providing the description of the event, and that this particular device (lot # f64398) did not unintentionally detach.The true complaint against this device is that there was resistance noted while attempting to advance the coil and was therefore removed.Based on the clarification provided, the incident description has now been corrected as follows: the patient was undergoing a coil embolization procedure for a recurrent aneurysm using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance and was unable to advance the pc400 into the px slim delivery microcatheter (px slim); therefore the pc400 was removed.The physician then completed the procedure using the same px slim and a new pc400.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6177157
• Report Number: 3005168196-2016-01814
• Device Sequence Number: 865654
• Product Code: HCG
• UDI-Device Identifier: 00814548011257
• UDI-Public: 00814548011257
• 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): 11/16/2016

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: 06/30/2023
• Device Catalogue Number: 4004J15
• Device Lot Number: F64398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR