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

Catalog Number	4006C0306
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pet lock was intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly; the stretch resistant wire was fractured and the proximal constraint sphere was inside the distal detachment tip (ddt); the embolization coil was damaged.Conclusions: evaluation of the returned device revealed that the pc400 coil sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted after resistance has been encountered, damage such as this may occur.The root cause of the initial resistance experienced when advancing the pc400 coil through the second non-penumbra microcatheter could not be determined.Pc400 coils are 100% functionally tested during process inspection.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 left internal iliac artery using penumbra coil 400 coils (pc400 coils).During the procedure, the physician advanced other manufacturers'' guide catheter and microcatheter coaxially into the patient and then deployed and detached six pc400 coils in the superior gluteal artery and three pc400 coils in the inferior gluteal artery.The physician then implanted another manufacturer¿s coil into the iliolumbar artery.Thereafter, the microcatheter was removed from the patient¿s body and another microcatheter from the same manufacturer was inserted into the patient.The physician then attempted to advance a pc400 coil through the microcatheter; however, resistance was encountered and therefore, the coil was retracted.The physician adjusted the position of the catheters and then made another attempt to advance the pc400 coil.However, resistance was encountered and the coil became stuck inside the microcatheter.Upon retracting the pc400 coil pusher assembly, the coil unintentionally detached within the microcatheter.The physician removed the microcatheter from the patient and then retracted the pc400 coil from it.The procedure was completed using a new pc400 coil.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: 5740219
• Report Number: 3005168196-2016-00842
• Device Sequence Number: 946476
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• 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
• Report Date (Section B): 05/22/2016

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: 12/26/2023
• Device Catalogue Number: 4006C0306
• Device Lot Number: F67075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2016
• Initial Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1