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

Catalog Number	4002C0310
Medical Device Problem Codes	Unraveled Material (1664); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was damaged but intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly.The pusher assembly was kinked approximately 70.0 and 71.5 cm from the proximal end.The pusher assembly was fractured approximately 164.0 cm from the proximal end with a kinked segment of the pull wire protruding from the fracture.The segment of the pusher assembly distal to the fracture, including the distal detachment tip (ddt), was not returned for evaluation.The embolization coil was detached from the pusher assembly, had a fractured stretch resistant (sr) wire, and was damaged throughout its length.Conclusions: evaluation of the returned devices revealed the pc400 pusher assembly and px slim were fractured.This damage likely occurred during the physician's attempt to retrieve the pc400.The segment of the pc400 pusher assembly distal to the fracture was not returned for evaluation.Further evaluation revealed the pc400 was damaged throughout its length, and the px slim was kinked.This damage may have occurred due to forceful handling during advancement of the pc400 through the px slim, or during packaging for return.Since the distal segment of the pusher assembly was not returned and both devices were returned severely damaged, the root cause of the complaint could not be determined.Px slim devices are 100% visually evaluated during in-process inspection, and pc400 devices are 100% visually and functionally evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-00230.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, while the physician was advancing the twenty-fourth pc400 coil through the px slim, the pc400 coil became stuck inside the px slim.While the coil was being retracted, it started to unravel inside the px slim.The physician removed both the pc400 coil and the px slim from the patient.The procedure was completed at this time since the angiography showed that the target vessel was occluded.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5461753
• Report Number: 3005168196-2016-00229
• Device Sequence Number: 375855
• Product Code: HCG
• UDI-Device Identifier: 00814548010458
• UDI-Public: 00814548010458
• 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
• Type of Report: Initial
• Report Date (Section B): 01/26/2016

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: 02/28/2019
• Device Catalogue Number: 4002C0310
• Device Lot Number: F26872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 72