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

Catalog Number	4002C1450
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations throughout its length and fractured, with the pull wire retracted out of the distal segment of the pusher assembly.The introducer sheath was kinked in multiple locations.The embolization coil was detached from the pusher assembly, was inside the introducer sheath, and had the proximal constraint sphere intact.Dried blood was observed throughout the introducer sheath and embolization coil.Conclusions: evaluation of the returned device revealed it was kinked and fractured, the pull wire was withdrawn, and the embolization coil was detached.This damage was likely incidental, and may have occurred during packaging for return to penumbra.Fracture of the pusher assembly may allow the pull wire to retract out of the distal detachment tip (ddt), which will allow the embolization coil to detach.Since the pusher assembly was fractured and the embolization coil was detached, the pc400 could not be functionally tested for advancement into a microcatheter, and the root cause of the reported advancement issues could not be determined.The lantern 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.This report is associated with mfr report number: 3005168196-2017-02132.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery using penumbra coil 400s (pc400s).It was noted that the patient anatomy was slightly tortuous and calcified.During the procedure, the physician placed a non-penumbra catheter in the left brachial artery, then advanced a lantern delivery microcatheter (lantern) coaxially toward the treatment site.The physician then successfully placed two pc400s in the target vessel.While attempting to advance a new pc400 through the microcatheter, the physician then was unable to advance the pc400 more than 4-5 cm out of its introducer sheath and into the lantern, and therefore the pc400 was re-sheathed.The physician attempted to advance the same pc400 again, however was unable to.The physician therefore removed the pc400 and lantern, and completed the procedure using a new lantern and new pc400s.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: 7083966
• Report Number: 3005168196-2017-02131
• Device Sequence Number: 1287967
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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: 02/05/2025
• Device Catalogue Number: 4002C1450
• Device Lot Number: F74296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1