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

Catalog Number	4006U0204
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2016
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.This report is associated with mfr report number: 3005168196-2016-00119.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400 coils).During the procedure, the physician successfully delivered three pc400 coils in the aneurysm using a px slim delivery microcatheter (px slim).While advancing a new pc400 coil through the px slim, the physician met resistance and the pc400 coil was removed.The physician then successfully advanced a new pc400 coil in the aneurysm, however, the physician had difficulty properly positioning the pc400 coil in the aneurysm and it unintentionally detached.A portion of the detached coil was hanging outside the aneurysm; therefore, the coil was successfully removed using a rescue device.A final angiography performed confirmed the case was completed successfully and no further action was required.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 penumbra coil 400 (pc400 coil) pusher assembly; the embolization coil was kinked and intact with the pusher assembly.Conclusion: evaluation of the returned devices revealed the first pc400 coil was kinked.This type of damages typically occurs due to improper handling during use.If the device is forcefully manipulated against resistance, damage such as this may occur.Further evaluation revealed the stretch resistance wire (sr wire) of the second pc400 coil was fractured.This damage likely occurred due to forceful withdrawal of the pc400 coil against resistance.The outer diameters (od) of the embolization coils were measured and found to be within specification.Pc400 coils are 100% functionally tested during in-process inspection.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: 5404463
• Report Number: 3005168196-2016-00118
• Device Sequence Number: 851245
• Product Code: HCG
• UDI-Device Identifier: 00814548011370
• UDI-Public: 00814548011370
• 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: Followup
• Report Date (Section B): 01/06/2016

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: 05/31/2023
• Device Catalogue Number: 4006U0204
• Device Lot Number: F63942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2016
• Supplement Report FDA Received Date: 02/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR