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

Catalog Number	RBY2C1260
Medical Device Problem Codes	Failure to Advance (2524); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01371.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a ruby coil and a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance the ruby coil through the px slim, the ruby coil became stuck inside of the px slim; therefore, physician attempted to retract it.While retracting the ruby coil no resistance was experienced; however, the ruby coil unintentionally detached inside of the px slim.The physician then attempted to remove the px slim containing the detached ruby coil; however, resistance was encountered and the physician was unable to remove the px slim.Therefore, the physician removed the guide catheter, the px slim and ruby coil together.The procedure was then completed using another microcatheter and other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil stretch resistant wire (sr wire) was fractured.The proximal constraint sphere was present on the proximal end of the embolization coil.The distal solder was present on the distal tip of the coil.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured.This type of damage typically occurs if the ruby coil was forcefully retracted against resistance.Furthermore, the ruby coil pusher assembly was not returned for evaluation.Evaluation of the returned px slim revealed that the distal shaft was kinked in multiple locations.If the peel-able sheath is not used during insertion into a parent device, damage such as this may occur.These kinks likely contributed to the returned ruby coil getting stuck in the px slim during the procedure and the reported resistance experienced when removing the px slim.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 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: 3005168196-2019-01371.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8795655
• Report Number: 3005168196-2019-01370
• Device Sequence Number: 16672970
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 11/05/2023
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F66355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/11/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005