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

Catalog Number	4004C0615
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	02/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was inside the distal detachment tip (ddt).The distal tip of the pusher assembly was stretched.The embolization coil was stuck inside the distal tip of its introducer sheath conclusions: evaluation of the returned device revealed that the pc400 sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device was forcefully retracted against resistance, damage such as this may occur.Further evaluation of the returned device revealed that the distal tip of the pusher assembly was stretched.This type of damage likely occurred due to forceful retraction against resistance.The slightly tortuous anatomy may have contributed to the reported resistance.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra 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 abdominal artery using penumbra coils 400 (pc400¿s).It was noted that the patient¿s anatomy was slightly tortuous.During the procedure, the physician deployed and detached a pc400 in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400 through the microcatheter, the physician mentioned resistance and subsequently, the pc400 unintentionally detached midway in the microcatheter.Therefore, the physician removed the microcatheter containing the detached and the procedure was completed using a new microcatheter, additional pc400¿s and pod coils.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: 7325368
• Report Number: 3005168196-2018-00459
• Device Sequence Number: 13480234
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• 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): 02/07/2018

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: 02/28/2024
• Device Catalogue Number: 4004C0615
• Device Lot Number: F68162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1