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

Catalog Number	4004C0820
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the subclavian artery using penumbra coil 400 (pc400s).During the procedure, after successfully deploying and detaching non-penumbra coils and pc400s using a non-penumbra microcatheter, the physician attempted to advance a 6th pc400 through the introducer sheath and into the microcatheter.However while advancing, the physician experienced a strong resistance and was unable to advance; consequently, the pusher wire became kinked and the pc400 was removed.The procedure was completed using the same microcatheter and an additional pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations and fractured approximately 37.0 cm from the proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed it was kinked and fractured.This damage may have occurred due to forceful advancement of the pc400 against resistance.If the pusher assembly becomes fractured, it may allow the pull wire to withdraw from the distal detachment tip (ddt), which would allow the embolization coil to detach.Since the embolization coil was not returned for evaluation, the root cause of the initial resistance experienced could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters are 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6583524
• Report Number: 3005168196-2017-00779
• Device Sequence Number: 1266937
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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,Followup
• Report Date (Section B): 04/23/2017

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: 12/11/2024
• Device Catalogue Number: 4004C0820
• Device Lot Number: F73143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Initial Date Received by Manufacturer: 04/23/2017
• Supplement Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1