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

Catalog Number	4002C1450
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	02/02/2018
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 and had offset coil winds.Conclusions: evaluation of the returned devices revealed that the first pc400 evaluated had offset coil winds.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated against resistance, damage such as this may occur.The root cause of the initial resistance could not be determined.However, the offset coil winds likely contributed to the initial resistance.Evaluation of the second returned device revealed that the pc400 was able to be advanced through the demonstration microcatheter and out its distal tip without an issue.Therefore, the root cause of the reported resistance for this coil could not be determined.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 internal iliac artery using penumbra coil 400''s (pc400¿s).During the procedure, while attempting to advance an initial pc400 into a non-penumbra microcatheter, the physician experienced resistance in the microcatheter and decided to remove the coil.A second pc400 was opened; however, the same resistance was experienced.Therefore, the physician removed the pc400 and successfully completed the procedure using five new pc400''s, two additional coils and the same microcatheter.There was no report of 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: 7327699
• Report Number: 3005168196-2018-00522
• Device Sequence Number: 1455911
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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): 02/09/2018

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: 02/05/2025
• Device Catalogue Number: 4002C1450
• Device Lot Number: F74296
• 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: 02/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1