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

Catalog Number	RBY2C0520
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was bent in multiple locations throughout its length.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned devices revealed both pusher assemblies were bent.This damage may have occurred due to forceful manipulation of the ruby coils during use.The damage observed on the pusher assemblies may have contributed to the ruby coils becoming stuck in the microcatheter during the procedure.Further evaluation revealed the first ruby coil evaluated could be advanced through the non-penumbra microcatheter, with some resistance experienced at the location of kink on the microcatheter.Evaluation of the second ruby coil evaluated revealed the stretch resistant (sr) wire was fractured.This type of damage typically occurs due to forceful retraction of the ruby coil against resistance.Evaluation of the non-penumbra microcatheter revealed it was kinked.If a ruby coil is forcefully withdrawn through a kinked microcatheter, it may contribute to the sr wire becoming fractured.The damage to the non-penumbra microcatheter may have also contributed to the ruby coils becoming stuck in the microcatheter during the procedure.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.This report is associated with mfr report number: 3005168196-2016-01474.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.It was reported that during the procedure, two ruby coils became stuck in the other manufacturer's microcatheter.It was also reported that one of the two ruby coils (lot #f68237) "deployed" in the microcatheter.Both ruby coils were removed and the procedure was completed using another system without any further issues.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush during the procedure.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6038780
• Report Number: 3005168196-2016-01478
• Device Sequence Number: 13659796
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/20/2016

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: 06/29/2023
• Device Catalogue Number: RBY2C0520
• Device Lot Number: F64676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1