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

Catalog Number	4006C0408
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned pc400 revealed that the sr wire was fractured.This type of damage typically occurs due to forceful retraction against resistance.The non-penumbra microcatheter identified in the complaint and the pc400 pusher assembly were not returned for evaluation.Therefore, the root cause of resistance could not be determined.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 pulmonary arteriovenous fistula using penumbra coil 400s (pc400s).During the procedure, while inserting a pc400 into a non-penumbra microcatheter, the physician experienced resistance and decided to remove the pc400.However, upon retraction, the pc400 unintentionally detached inside the microcatheter.The physician then attempted to push the detached coil into the target vessel using the pusher assembly; however, it was unsuccessful.Therefore, the physician removed the microcatheter containing the detached coil from the patient.The procedure was completed using the same microcatheter and eight additional pc400s.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: 8197078
• Report Number: 3005168196-2018-02512
• Device Sequence Number: 2165380
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• Combination Product (Y/N): Y
• 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): 11/27/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 07/18/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F78240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/26/2018
• 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
• Date Report Sent to FDA: 01/01/2005