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

Catalog Number	4002C2860
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached from its pusher assembly.The outer diameter (od) of the embolization coil and the proximal constraint sphere were measured and found to be within specification.The coil windings were offset.Conclusions: evaluation of the returned device revealed that the pc400 embolization coil and proximal constraint sphere od was within specification.The non-penumbra microcatheter mentioned in the complaint and the pc400 pusher assembly were not returned for evaluation.Therefore, the root cause of the resistance experienced by the physician, and the unintentional detachment of the embolization coil could not be determined.The offset coil windings likely occurred due to forceful advancement against resistance.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 to treat a renal arteriovenous fistula (avf) using penumbra coil 400's (pc400's).During the procedure, while attempting to deploy the first pc400, the physician deployed about fifteen centimeters of the coil into the target vessel and then encountered rapid blood flow from the shunt, which pushed the coil aside.The physician then decided to retract the pc400 in order to reposition the balloon catheter.While manipulating the pc400 so that it could be retracted back into the non-penumbra microcatheter, the physician encountered resistance and subsequently, the pc400 unintentionally detached within the microcatheter.Therefore, the physician removed the microcatheter containing the detached pc400 from the patient and then flushed the coil out of the microcatheter with saline.Thereafter, the procedure was completed using the same non-penumbra microcatheter and a new pc400.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: 6347996
• Report Number: 3005168196-2017-00219
• Device Sequence Number: 673024
• Product Code: HCG
• UDI-Device Identifier: 00814548011981
• UDI-Public: 00814548011981
• 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): 01/22/2017

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: 06/14/2024
• Device Catalogue Number: 4002C2860
• Device Lot Number: F70152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR