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

Catalog Number	4004C1030
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
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 in the internal iliac artery using penumbra coils 400 (pc400s).During the procedure, the physician placed three pc400s in the target vessel using a non-penumbra microcatheter.While attempting to advance the fourth pc400 through the microcatheter, the physician experienced resistance after advancing the pc400 pusher assembly only a couple of centimeters into the hub of the microcatheter; therefore, it was removed.The physician then re-attempted to advance the pc400 into the microcatheter; however, the coil would not advance.Therefore, the pc400 was removed and the procedure was completed using four additional pc400s and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the pusher assembly.The introducer sheath was occluded with dried blood on its distal tip.The embolization coil was intact with the pusher assembly and was covered in dried blood.Evaluation of the returned device revealed there was dried blood that covered the embolization coil and occluded the distal tip of the introducer sheath.This dried blood prevented the penumbra coils 400 (pc400) from advancing out of the introducer sheath, even when the distal tip of the introducer sheath was skived off.If continuous flush is not used during advancement of the pc400, blood may dry within the introducer sheath and prevent the pc400 from advancing.The non-penumbra microcatheter 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: 6843163
• Report Number: 3005168196-2017-01499
• Device Sequence Number: 800317
• Product Code: HCG
• UDI-Device Identifier: 00814548010977
• UDI-Public: 00814548010977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 03/14/2025
• Device Catalogue Number: 4004C1030
• Device Lot Number: F75029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1