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

Catalog Number	4004C0615
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
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: 3005168196-2017-01146.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right carotid terminus using penumbra coil 400's (pc400's) and a penumbra coil detachment handle (handle).During the procedure, the physician deployed a pc400 into the target vessel but was unable to detach the coil using the handle.Therefore, the pc400 was removed and 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
The pet lock was broken, the hypotube was fractured near the proximal end, and the pull tube and pull wire were completely withdrawn out of the hypotube.The penumbra coil 400 (pc400) pusher assembly was kinked approximately 64.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and the pull wire was withdrawn out of the distal detachment tip (ddt).Evaluation of the returned pc400 revealed that the proximal end of the hypotube was broken and the pull wire was completely withdrawn out of the pusher assembly.This type of damage typically occurs when an attempt to manually detach the coil is made.Since the embolization coil was detached, and the pull wire and embolization coil were both not returned for evaluation, the root cause of the inability to detach the coil could not be determined.The kink observed in the pusher assembly was likely incidental and may have occurred during packaging for return.The penumbra coil detachment handle (handle) had no visible damage, and passed for all functional specifications during functional testing.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually and functionally inspected during incoming quality inspection.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: 6703893
• Report Number: 3005168196-2017-01145
• Device Sequence Number: 1566382
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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: 10/16/2024
• Device Catalogue Number: 4004C0615
• Device Lot Number: F72308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR