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

Catalog Number	PXSLIMSTR
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was intact with the pusher assembly.The px slim delivery microcatheter (px slim)was kinked approximately 2.0 cm from the proximal end.Conclusion: evaluation of the returned devices revealed the pc400 could be advanced through a demonstration microcatheter without issue.Further evaluation revealed the px slim was kinked near the hub.This damage may have occurred due to forceful handling of the px slim during preparation or positioning within patient anatomy.The kinked region likely contributed to the inability to advance the pc400 during the procedure.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.This report is associated with mfr report number: 3005168196-2017-01429.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed pc400s using a px slim delivery microcatheter (px slim).The physician then felt resistance advancing a pc400 through its introducer sheath and into the microcatheter, and was unable to advance the pc400 through the px slim; therefore, the pc400 was removed.It was noticed that the px slim was kinked near the strain relief on the proximal end of the catheter; therefore, the px slim was removed.The procedure was completed using a new pc400 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: 6810485
• Report Number: 3005168196-2017-01430
• Device Sequence Number: 985653
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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: 10/25/2019
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F72473
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR