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

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the third ruby coil evaluated.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath had coagulated blood inside.Conclusions: evaluation of the first returned device revealed that the ruby coil¿s pusher assembly was kinked in multiple locations.This damage was likely accidental during advancement of the ruby coil into the lantern on the back table as mentioned in the complaint.The kinks in the pusher assembly prevented the returned ruby coil from being functionally tested through a demonstration microcatheter.Evaluation of the returned device revealed that the podj¿s pet lock was broken and the pull wire was retracted out of the ddt.This type of damage typically occurs due to improper handling during use.If pet lock is broken and the pull wire is retracted out of the ddt during manipulation of the device, by design, the embolization coil will detach from its pusher assembly.The pull wire being retracted out of the ddt likely caused the embolization coil to detach from its pusher assembly.Evaluation of the second returned device revealed that the ruby coil was functional.The ruby coil was advanced through a demonstration microcatheter and out of the distal tip without an issue.Evaluation of the third returned device revealed that the ruby coil¿s pusher assembly was kinked and the introducer sheath had coagulated blood inside.The kink in the pusher assembly was likely accidental during advancement of the ruby coil into the lantern as mentioned in the complaint.The coagulated blood prevented the ruby coil from being advanced through the demonstration microcatheter during functional testing.Evaluation of the returned lantern revealed that the microcatheter distal shaft was repeatedly kinked.This type of damage likely occurred due to forceful manipulation during placement of the ruby coils.These kinks likely contributed to the ruby coil unintentionally detaching within the microcatheter.A mandrel could not be completely advanced through the returned lantern during functional testing.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2017-02119, 3005168196-2017-02120.3005168196-2017-02121.

Event Description

The patient was undergoing a coil embolization procedure using pod packing coils (podjs) and a lantern delivery microcatheter (lantern).During preparation for the procedure, the hospital technician accidentally kinked two ruby coils while advancing them into the lantern on the back table.A third ruby coil also became kinked during preparation on the back table.The damage to these ruby coils occurred prior to use, and therefore they were not used in the procedure.During the procedure, the physician successfully placed ruby coils using the same lantern.The physician then experienced difficulty placing a podj within the target location and, consequently, the podj unintentionally detached as the physician was manipulating it.The physician therefore removed the lantern with the podj inside, and the procedure was completed using a new lantern and additional ruby coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2017-02122.This report is associated with mfr report numbers: 3005168196-2017-02119, 3005168196-2017-02120, 3005168196-2017-02121.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7089416
• MDR Text Key: 95074656
• Report Number: 3005168196-2017-02122
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/06/2017

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
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 57