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

Catalog Number	PXSLIM045
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was kinked approximately 3.0, 50.0, and 73.0 cm from the proximal hub.There was a penumbra pusher assembly returned inside the px slim that protruded distal to the px slim distal tip but was not visible in the proximal hub.The pusher assembly was visible starting approximately 42.0 cm from the hub.During functional analysis, the pusher assembly was removed from the px slim revealing a fracture on its proximal end.A demonstration coil was advanced through the length of the px slim and out the distal tip without issue.However, the px slim was unable to be advanced pass the proximal ovalization in the non-penumbra catheter.Conclusions: evaluation of the returned devices revealed kinks in the non-penumbra catheter.These kinks likely caused the px slim¿s inability to advance farther than approximately 50.0 cm into the non-penumbra catheter.Evaluation of the returned devices also revealed a fractured pusher assembly inside the px slim.The pusher assembly was advanced out the distal tip of the px slim.It was observed that the pusher assembly and px slim were kinked in parallel.These damages suggest that the kinks happened while the pusher was inside the px slim and, based on the severity and location of the kinks, likely occurred after the procedure.Penumbra cannot confirm the reported issue of difficulty advancing as a pusher assembly was returned fully advanced through the catheter.The root cause of the damages on the px slim could not be determined.Further evaluation revealed that the pusher assembly was protruding distally from the px slim but was fractured within the px slim approximately 40.0 cm from the hub.There was no information reported in the complaint regarding this damage.Therefore, the root cause could not be determined.The penumbra coil 400's (pc400's) cited in the complaint were not returned for evaluation.Penumbra catheters and 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 numbers: 3005168196-2017-01738, 3005168196-2017-01739.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal thoracic artery using penumbra coil 400''s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a non-penumbra angiographic catheter towards the target vessel and then attempted to advance the px slim through the catheter; however, resistance was encountered and after advancing the px slim approximately fifty centimeters into the catheter, the physician was unable to advance the px slim any further.The physician then switched to another non-penumbra angiographic catheter and successfully advanced the same px slim through the catheter.Next, the physician deployed and detached nine pc400s into the target vessel using the px slim.While attempting to advance a new pc400 through the px slim, the physician experienced resistance and was unable to advance the coil.Therefore, the physician removed the pc400 and attempted to advance a new pc400 through the px slim; however, resistance was encountered again and the new pc400 would not advance at all.Therefore, the pc400 and px slim were both removed and the procedure was completed using two additional pc400s and a new px slim.There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6943274
• Report Number: 3005168196-2017-01737
• Device Sequence Number: 124409
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 03/31/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F68755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 11