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

Catalog Number	4004C0820
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	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was intact with its pusher assembly.The introducer sheath was ovalized approximately 7.0 cm from the distal tip.During functional analysis, the pc400 was attempted to be advanced through a demonstration microcatheter.While attempting to advance the pc400 through the introducer sheath; resistance was encountered as the pc400 was being advanced through its introducer sheath.Once the proximal end of the embolization coil met the ovalization in the introducer sheath, the pc400 could not be advanced any further.Conclusions: evaluation of the returned device revealed that the pc400 introducer sheath was ovalized.This type of damage typically occurs due to improper handling during use.If the rotating hemostasis valve (rhv) is overtightened on the introducer sheath prior to advancement, damage such as this may occur.The ovalization in the introducer sheath caused the resistance that was felt during the procedure and prevented the pc400 from being advanced through the microcatheter.The px slim referred to in the complaint was not returned for evaluation.Penumbra coils are visually 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
The patient was undergoing a coil embolization procedure in the pulmonary artery using penumbra coil 400's (pc400s).It was reported that the patient had moderately tortuous vessels.During the procedure, the while attempting to advance a pc400 through its introducer sheath and into the px slim delivery microcatheter (px slim), the physician encountered resistance but continued to advance the coil; however, the pc400 was unable to advance any further and did not reach the hub of the microcatheter.Therefore, the introducer sheath containing the pc400 was removed and the procedure was successfully completed using a four new pc400's, seven additional coils and the same px slim.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: 7216962
• Report Number: 3005168196-2018-00205
• Device Sequence Number: 16430596
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2017

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: 08/22/2025
• Device Catalogue Number: 4004C0820
• Device Lot Number: F78853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1