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

Catalog Number	4004C0513
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked approximately 5.0, 49.0, and 52.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The outer diameter of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the returned device revealed that the od of the embolization coil was measured and found to be within specification.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.The root cause of the embolization coil not be able to advance out of the distal tip of the non-penumbra microcatheter could not be determined.Further evaluation revealed that the pusher assembly was kinked.This type of damage typically occurs due to forceful handling during use.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a pancreatic fistula using penumbra coil 400's (pc400's).During the procedure, the physician deployed and detached three pc400 in the fistula using another manufacturer balloon catheter with no issues.While attempting to advance the fourth pc400 through the balloon catheter, the physician experienced resistance and the pc400 became stuck and unable to advance.Therefore, the pc400 was removed and the procedure was completed using the same balloon catheter and new pc400's.The physician reported flushing between each coil and not using a rotating hemostasis valve.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: 6149384
• Report Number: 3005168196-2016-01773
• Device Sequence Number: 18845159
• Product Code: HCG
• UDI-Device Identifier: 00814548010861
• UDI-Public: 00814548010861
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2016

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: 06/12/2024
• Device Catalogue Number: 4004C0513
• Device Lot Number: F70129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 75