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

Model Number	4002C1450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 using penumbra coils 400 (pc400¿s).During the procedure, while attempting to insert a pc400 into the microcatheter, the pc400 detached in its introducer sheath; therefore, it was removed.The procedure was completed using a new pc400 and the same microcatheter.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 and the pull wire was completely retracted out of the pusher assembly.The pusher assembly was fractured approximately 26.5 cm from the proximal end.The embolization coil was detached from its pusher assembly and the proximal constraint sphere was present.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly was fractured.If the device is forcefully advanced against resistance the pusher assembly may become kinked.If the damaged pusher assembly is subsequently mishandled, damage such as a fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed that embolization coil was detached from its pusher assembly.When the pusher assembly fractures it may allow the pull wire to retract from the distal detachment tip, effectively detaching the embolization coil.The microcatheter identified in the complaint was not returned to penumbra for evaluation.Penumbra coils and catheters 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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7545065
• Report Number: 3005168196-2018-01053
• Device Sequence Number: 16187405
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018
• 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: 03/07/2025
• Device Model Number: 4002C1450
• Device Catalogue Number: 4002C1450
• Device Lot Number: F74863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 01/14/2005
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 07/02/2018; 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005