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

Catalog Number RBY2C1260

Device Problems Failure to Advance (2524); High Sensing Threshold (2574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery using ruby coils.During the procedure, the physician placed the initial coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new ruby coil through the same lantern, the physician experienced resistance and subsequently, the ruby coil would not advance; therefore, it was removed.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the ruby coil was detached and, therefore, could not be functionally tested for advancement through a microcatheter.Conclusions: evaluation of the returned device revealed the ddt was fractured off and the embolization coil was detached within the introducer sheath.The location of the fractured ddt and detached coil suggest this damage was incidental to the reported resistance and inability to advance.The root cause of the initial resistance could not be determined.The lantern referenced in the complaint was 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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7332599
• MDR Text Key: 102200441
• Report Number: 3005168196-2018-00543
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• 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,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F73649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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 Age: 70 YR