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

Catalog Number	RBY4C0202
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
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 in the gastroduodenal artery using ruby coils.During the procedure, a ruby coil would not deploy; therefore, it was removed.The procedure was completed using another coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly was kinked throughout its length.The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned device revealed the pet lock was broken and the embolization coil was detached.A broken pet lock indicates that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the coil with a handle.Since the coil was detached as intended, the root cause of the reported inability to deploy could not be determined.The kinks observed throughout the pusher assembly were likely incidental and may have occurred during packaging for return.The embolization coil and non-penumbra microcatheter mentioned in the complaint 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7162586
• Report Number: 3005168196-2018-00021
• Device Sequence Number: 1497249
• Product Code: HCG
• UDI-Device Identifier: 00814548013121
• UDI-Public: 00814548013121
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/05/2017

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
• Operator of Device: Physician
• Device Expiration Date: 05/09/2024
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F69273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR