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

Catalog Number	4002C0512
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
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.This report is associated with mfr report number: 3005168196-2017-00544.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400''s (pc400's).During the procedure, the physician deployed and detached five pc400's into the target vessel using a non-penumbra catheter and a penumbra coil detachment handle (handle).The physician then had deployed a sixth pc400 (lot # a25537) into the patient but had difficulty detaching the coil using the same handle.After several attempts, the physician was able to detach the coil.Next, the physician deployed a seventh pc400 (lot # f70957) into the patient and attempted to detach the coil using the same handle.However, after several attempts, the pc400 was unable to detach and was removed.Thereafter, the procedure was completed using a new pc400 and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pull wire was not present with the penumbra coil 400 (pc400) pusher assembly.The pc400 pusher assembly was kinked approximately 5.0 cm from the proximal end of the pusher assembly.The embolization coil was returned detached from the pusher assembly and coagulated blood was on the proximal end of the embolization coil.There was coagulated blood present inside the pusher assembly hypotube.There was offset coil winds along the length of the embolization coil.The pc400 was returned with the embolization coil detached from the pusher assembly and was therefore, not functionally evaluated.Conclusions: evaluation of the returned device revealed that the pull wire had been fully retracted from the pusher assembly and the embolization coil was detached.This damage was likely incidental and was likely done after the procedure in question was deemed complete.The lack of a rotating hemostasis valve (rhv) and continuous flush likely contributed to the coagulated blood found on the embolization coil and inside the pusher assembly hypotube.This blood could have possibly contributed to some difficulty when attempting to detach the embolization coil.However, due to the returned state of the device, the root cause of this failure could not be determined.Further evaluation revealed offset coil winds along its length.This damage was likely due to repeated manipulations of the coil against resistance.The pull wire and 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: 6465475
• Report Number: 3005168196-2017-00543
• Device Sequence Number: 16295841
• Product Code: HCG
• UDI-Device Identifier: 00814548013398
• UDI-Public: 00814548013398
• 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,Followup
• Report Date (Section B): 03/09/2017

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: 08/01/2024
• Device Catalogue Number: 4002C0512
• Device Lot Number: F70957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR