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

Catalog Number	4006C0408
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was damaged on the proximal end of the pusher assembly, but not broken.The pusher assembly was kinked approximately 114.0 cm from the proximal end.The pull wire was completely retracted out of the distal detachment tip (ddt) and the embolization coil was detached from its pusher assembly.The ddt had coagulated blood inside.Conclusions: evaluation of the returned pc400 revealed that the pull wire was retracted out of the ddt and the embolization coil was detached from its pusher.If the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.The pet lock on the proximal end of the pusher assembly was damaged, but not broken.The root cause of the pull wire being retracting out of the ddt could not be determined.Further evaluation of the returned pc400 revealed that the pusher assembly was kinked.This kink was likely incidental to the reported issue and may have occurred while packaging the device for return to penumbra.The px slim identified in the complaint and the introducer sheath to the pc400 were not returned to penumbra for evaluation.Penumbra coils and catheters are visually 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 in the splenic artery using penumbra coils 400 (pc400¿s).During the procedure, the physician successfully deployed and detached a pod coil in the target vessel using a px slim microcatheter (px slim).While attempting to insert a pc400 into the px slim, the physician noticed that the coil did not advance into the microcatheter.The physician then looked around and noticed that the embolization coil was on the ground.The procedure was completed using another pc400, other coils and the same px slim.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: 7575928
• Report Number: 3005168196-2018-01107
• Device Sequence Number: 217559
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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): 05/09/2018

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: 07/18/2025
• Device Catalogue Number: 4006C0408
• Device Lot Number: F78240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1