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

Catalog Number	RBY2C0930
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned ruby coil revealed the pet lock was separated and the embolization coil was detached.If the proximal end of the pusher assembly is forcefully manipulated, the pet lock may unintentionally separate, which will cause the pull wire to withdraw and the embolization coil to detach.The pusher assembly kinks were likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the returned pod6 revealed the pet lock and embolization coil were intact on the pusher assembly.Therefore, the reported pet lock separation and unintentional detachment could not be confirmed.The pod6 pusher kinks were likely incidental and may have occurred during packaging for return.The other ruby coil and lantern mentioned in the complaint, as well as the pod6 introducer sheath, were 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 numbers: 3005168196-2018-00382, 3005168196-2018-00383.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery using ruby coils and pod6.During the procedure, while attempting to place a ruby coil between the arterial and venous connection in a figure 8 fashion using a lantern delivery microcatheter (lantern), the physician aggressively applied forward tension on the lantern and moved the coil in and out the treatment site.Consequently, the pusher assembly pet lock became damaged and subsequently, the ruby coil unintentionally detached.Therefore, the physician attached a syringe to the back of the lantern and pulled negative pressure back.Thus, the detached coil was aspirated out.It was reported that the same issue occurred with another ruby coil and pod6.Both coils were also aspirated out after the unintentional detachment and the lantern removed.The procedure was completed using a new lantern and additional ruby coils.It should be noted that there was no noted damage or issue with the initial lantern.The physician just wanted to start fresh with a new lantern.Additionally, there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Event description corrected.This report is associated with mfr report numbers: 3005168196-2018-00382, 3005168196-2018-00383, 3005168196-2018-00825.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery using ruby coils and pod6.During the procedure, while attempting to place a ruby coil between the arterial and venous connection in a figure 8 fashion using a lantern delivery microcatheter (lantern), the physician aggressively applied forward tension on the lantern and moved the coil in and out the treatment site.Consequently, the pusher assembly pet lock became damaged and subsequently, the ruby coil unintentionally detached.Therefore, the physician attached a syringe to the back of the lantern and pulled negative pressure back.Thus, the detached coil was aspirated out.It was reported that the same issue occurred with another ruby coil and pod6.Both coils were also aspirated out after the unintentional detachment.While attempting to advance a new ruby coil through the lantern, the ruby coil pusher assembly became bent and kinked after aggressive forward and backward motion.Therefore, the ruby coil and lantern were removed.The procedure was completed using a new lantern and additional ruby coils.It should be noted that there was no noted damage or issue with the initial lantern.The physician just wanted to start fresh with a new lantern.Additionally, there was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7288915
• Report Number: 3005168196-2018-00384
• Device Sequence Number: 19395275
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 10/30/2024
• Device Catalogue Number: RBY2C0930
• Device Lot Number: F72596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 86