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

Catalog Number	4002C1145
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly.The pusher assembly was kinked approximately 100.0 and 122.0 cm from the proximal end.The introducer sheath was ovalized approximately 7.0 cm from the distal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the introducer sheath was ovalized.This type of damage typically occurs due to overtightening of a hemostasis valve on the introducer sheath.The ovalization found on the introducer sheath likely contributed to the difficulty advancing the pc400.The kinks in the pusher assembly likely occurred due to forceful advancement of the pc400 against resistance.Pc400 devices are 100% 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, the physician successfully deployed and detached an initial pc400 coil into the aneurysm.While preparing a new pc400 coil for the procedure, the hospital staff found that the coil was unable to advance out of its introducer sheath and into the bath before introducing it into the patient.Therefore, the second pc400 coil was not used for the procedure and did not enter the patient's body.The procedure was completed using new pc400 coils.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5498856
• Report Number: 3005168196-2016-00310
• Device Sequence Number: 499087
• Product Code: HCG
• UDI-Device Identifier: 00814548010625
• UDI-Public: 00814548010625
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2016

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: 06/30/2023
• Device Catalogue Number: 4002C1145
• Device Lot Number: F64514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2016
• Initial Report FDA Received Date: 03/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1