MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number	PXSLIM090-A
Medical Device Problem Codes	Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2016
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.This report is associated with mfr report numbers: 3005168196-2016-00881, 3005168196-2016-00882, 3005168196-2016-00883, 3005168196-2016-00885.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and px slim delivery microcatheters (px slim).During the procedure, the physician advanced a ruby coil (lot #f68557) into the target vessel using the px slim but did not like position of the coil and decided to remove the coil from the patient.However, while retracting the ruby coil, the physician experienced resistance and subsequently, the coil unintentionally detached inside the px slim.The px slim containing the ruby coil was then removed from the patient.Next, the physician opened a new px slim and attempted to advance a new ruby coil (lot #f68732) through it.While advancing the ruby coil, the physician experienced resistance and the coil unintentionally detached inside the px slim.Therefore, both the ruby coil and the px slim were removed.The physician then opened a new ruby coil (lot #f67989) and a lantern delivery microcatheter (lantern) to continue the procedure.While the ruby coil was being introduced into the lantern, the ruby coil pusher assembly became kinked and was therefore, removed without any issue.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the first px slim delivery microcatheter (px slim) evaluated had an embolization coil stuck in the distal tip and was ovalized approximately 138.0 cm from the hub.Conclusions: evaluation of the returned devices revealed both px slim's were ovalized in their distal shafts.These damages may have occurred due to forceful gripping or pinching of the px slim's during preparation or insertion into a catheter.The ovalizations likely contributed to the resistance experienced while advancing and retracting the ruby coils through the px slim's.Evaluation of the first and second ruby coils used in the procedure revealed the embolization coils were detached from the pusher assemblies and the stretch resistant (sr) wires were fractured.Sr wire fracture typically occurs due to forceful retraction of the ruby coil against resistance, and will cause the embolization coil to detach.The ovalizations in the px slim's likely contributed to the resistance experienced during advancement of these two ruby coils.Evaluation of the third ruby coil used in the procedure revealed the pusher assembly was kinked.This damage likely occurred due to forceful manipulation of the ruby coil during insertion into the lantern, as was reported in the complaint.The lantern mentioned in the complaint was not returned for evaluation.All 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: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5749269
• Report Number: 3005168196-2016-00884
• Device Sequence Number: 18832813
• Product Code: DQY
• UDI-Device Identifier: 00814548010342
• UDI-Public: 00814548010342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2016

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: 11/30/2018
• Device Catalogue Number: PXSLIM090-A
• Device Lot Number: F66312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2016
• Supplement Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR