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); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
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 left subclavian artery using penumbra coils 400 (pc400s).During the procedure, while attempting to advance a pc400 through a non-penumbra microcatheter, the physician experienced excessive resistance and the pc400 was unable to advance further than halfway in the microcatheter.Therefore, it was removed.The procedure was completed using three additional pc400s and the same microcatheter without further issues.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 fractured approximately 71.0 cm from the proximal end and kinked approximately 31.0, 104.0, and 106.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and the pull wire was protruding from the distal detachment tip (ddt).Conclusions: evaluation of the returned device revealed the embolization coil had offset coil winds, the pull wire protruded from the ddt, and the pusher assembly was kinked and fractured.The offset coil winds and protruding pull wire may have occurred due to forceful manipulation of the embolization coil within patient anatomy, and likely contributed to the resistance experienced during the procedure.The pusher assembly kinks and fracture likely occurred due to forceful advancement of the pc400 against resistance.The non-penumbra microcatheter mentioned in the complaint and the pc400 introducer sheath were not returned for evaluation.Penumbra coils 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: 6616235
• Report Number: 3005168196-2017-00861
• Device Sequence Number: 808724
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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: 04/19/2024
• Device Catalogue Number: 4002C1450
• Device Lot Number: F69028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR