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

Catalog Number	4006U0310
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, while attempting to advance a pc400 out of its introducer sheath, the physician experienced resistance and the pc400 was unable to advance out of its introducer sheath.The physician reported using a rotating hemostasis valve and maintaining continuous flush.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 penumbra coil 400 (pc400) pusher assembly.The introducer sheath was kinked approximately 5.0 cm from its distal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the introducer sheath was kinked.This damage may have occurred due to forceful manipulation of the pc400 during preparation for insertion into the px slim.The kink in the introducer sheath likely caused the resistance experienced by the physician during the procedure.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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: 6226278
• Report Number: 3005168196-2017-00011
• Device Sequence Number: 1027672
• Product Code: HCG
• UDI-Device Identifier: 00814548011462
• UDI-Public: 00814548011462
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2016

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: 01/19/2024
• Device Catalogue Number: 4006U0310
• Device Lot Number: F67520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 03/14/2017
• 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