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

Catalog Number RBY2C0410

Device Problems Split (2537); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.The distal tip of the ruby coil¿s embolization coil had offset coil winds.Conclusions: evaluation of the returned device revealed that the ruby coil was embolization coil had offset coil winds.This damage may have occurred due to forceful manipulation of the ruby coil through a damaged microcatheter or against another source of resistance.The offset coil winds likely contributed to the resistance experienced during advancement.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.The ruby coil was attempted to be advanced through a demonstration microcatheter; however, the ruby coil could not be re-sheathed due to the offset coil winds.Therefore, the ruby coil could not be functionally tested though a demonstration microcatheter.Penumbra coils 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.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician experienced resistance while advancing a ruby coil through a non-penumbra microcatheter, and reported that under fluoroscopy it appeared that the ruby coil distal end was split.Therefore, the microcatheter was removed with the ruby coil inside.The procedure was then completed using the same microcatheter and additional ruby coils.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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7131738
• MDR Text Key: 95344765
• Report Number: 3005168196-2017-02286
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F78624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• 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: 53 YR
• Patient Weight: 64