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

Catalog Number	RBY2C0620
Medical Device Problem Codes	Bent (1059); Detachment Of Device Component (1104); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Serious Injury
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.The embolization coil was detached from the pusher assembly and unraveled, and the stretch resistant wire (sr wire) was fractured.Conclusions: evaluation of the returned device revealed the embolization coil was detached and unraveled, and the sr wire was fractured.Fracture of the sr wire typically occurs due to forceful retraction of the ruby coil against resistance, and will allow the embolization coil to detach and unravel.Further unraveling of the ruby coil may have occurred during retrieval via snare device.Further evaluation of the returned device revealed the pusher assembly was kinked in multiple locations.The observed kinks to the pusher assembly may have contributed to the lantern kicking back into the parent catheter, as reported in the complaint.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.
Event or Problem Description
The patient was undergoing a coil embolization to treat a liver arteriovenous malformation (avm) using ruby coils.It was reported that coils were previously placed in the target vessel during previous cases.During the procedure, while attempting to advance a ruby coil through a lantern delivery microcatheter (lantern), the physician inadvertently bent the ruby coil pusher assembly.The physician was advised to remove the ruby coil; however, the physician insisted that the ruby coil was fine and did not remove the ruby coil.It was reported that while attempting to place the ruby coil into the aneurysm, the lantern kicked back into the catheter and the physician did not like the way the ruby coil was positioning in the aneurysm.After repositioning the ruby coil several times, it unintentionally detached from the pusher assembly with half of the ruby coil inside the lantern and the other half in the patient¿s body.The physician used a snare device to remove the detached ruby coil.The physician then regained access, placed and inflated a non-penumbra balloon catheter in order to attempt to use glue; however, the patient was unstable and the physician was unable to use the glue.The patient subsequently expired on the table from hemorrhage.The physician does not attribute the patient's death to the penumbra device.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6555829
• Report Number: 3005168196-2017-00717
• Device Sequence Number: 533359
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/24/2023
• Device Catalogue Number: RBY2C0620
• Device Lot Number: F64610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 DA
• Patient Weight: 2