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

Catalog Number	RBY2C0420-A
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while the physician was attempting to advance a ruby coil through another manufacturer's microcatheter, the ruby coil would not advance out of its introducer sheath.The ruby coil was removed and the physician then attempted to use two other microcatheters from the same manufacturer but was unsuccessful.Therefore, the procedure was completed using a new ruby coil and another manufacturer's microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the introducer sheath was ovalized approximately 41.5 cm from the proximal end; the embolization coil was intact with the pusher assembly and compressed on the proximal end.Conclusion: evaluation of the returned device revealed that the ruby coil introducer sheath was ovalized.This type of damage typically occurs due to improper handling during use.If the device is forcefully gripped or pinched during use, damage such as this may occur.Further evaluation revealed that the embolization coil was compressed on the proximal end.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated during the attempt to advance the embolization coil out of its introducer sheath, damage such as this may occur.The ovalization in the introducer sheath and the embolization coil being compressed on the proximal end likely prevented the embolization coil from advancing out of its introducer sheath.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation and, therefore, the root cause of the initial resistance could not be determined.All penumbra coils 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5730979
• Report Number: 3005168196-2016-00819
• Device Sequence Number: 16271339
• Product Code: HCG
• UDI-Device Identifier: 00814548012865
• UDI-Public: 00814548012865
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 05/18/2016

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: 03/23/2024
• Device Catalogue Number: RBY2C0420-A
• Device Lot Number: F68661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• Supplement Report FDA Received Date: 09/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR