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

Catalog Number	4002C1557
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
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 using penumbra coil 400's (pc400s).During the procedure, the physician successfully deployed and detached a pc400 into the target vessel using a px slim delivery microcatheter (px slim).While attempting to advance a new pc400 out of its introducer sheath and into the px slim, the physician encountered resistance when the coil was at the tip of its introducer sheath.Subsequently, the pc400 became stuck and was unable to advance out of its introducer sheath and into the px slim.Therefore, the introducer sheath containing the pc400 was removed and the procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The sterile pouch was unopened and there was no visible damage to the packaging or the penumbra coil 400 (pc400).No functional testing was performed.The returned device was inside its original, unopened packaging and, therefore, the root cause of the reported issue could not be determined.The px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation.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: 6745648
• Report Number: 3005168196-2017-01252
• Device Sequence Number: 762568
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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): 06/30/2017

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: 01/23/2024
• Device Catalogue Number: 4002C1557
• Device Lot Number: F67574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR