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

Catalog Number RBY4C0315-A

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Migration or Expulsion of Device (1395); Difficult To Position (1467); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Portion of device was implanted in pst.

Event Description

The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) for a pseudo-aneurysm using ruby coils.During the procedure, the physician successfully deployed and detached two ruby coils into the pseudo-aneurysm.While attempting to deploy a new ruby coil, the physician was unable to place the coil in the desired location and decided to remove it; however, the ruby coil unintentionally detached and the physician required a snare device to remove the coil.While the ruby coil was being removed from the patient, it began to unravel.The physician was able to remove most of the coil except for a portion of it, which migrated to the iliac artery.The physician left the piece of the ruby coil in the patient because it was insignificant and was not flow limiting.No other ruby coils were needed since the pseudo-aneurysm was successfully treated.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5330977
• MDR Text Key: 34519889
• Report Number: 3005168196-2015-01349
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: RBY4C0315-A
• Device Lot Number: F64298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR