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

Model Number	PXSLIM130-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using a px slim delivery microcatheter (px slim).It was noted that the patient had a tortuous anatomy.During the procedure, while attempting to advance a px slim into another manufacturer's 4f catheter with a guide wire, the physician experienced resistance around the color transition part at the tip of the px slim and subsequently, the px slim became stuck inside the 4f catheter.Therefore, the physician removed the px slim and the 4f catheter, then opened a new 4f catheter.While attempting to advance the same px slim through the new 4f catheter, resistance was encountered again at the same position and the px slim became stuck inside the 4f catheter.Therefore, the physician removed the px slim and continued the procedure by taking a diagnostic angiography through the 4f catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim was kinked four times between approximately 145.0 and 147.0 cm from its proximal hub.For reference, the max outer diameter (od) for the px slim is 0.040¿.Conclusions: evaluation of the px slim revealed multiple kinks in its distal region.This damage was a result of the dimensional incompatibility of the non-penumbra catheter and px slim.The non-penumbra catheter was designed to accommodate a maximum of 0.038¿ while the max od of the px slim is 0.040¿.Therefore, extreme resistance can be expected when attempting to advance the px slim through this non-penumbra catheter.Penumbra 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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2017-00885.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6618456
• Report Number: 3005168196-2017-00885
• Device Sequence Number: 231733
• Product Code: DQY
• UDI-Device Identifier: 00814548012537
• UDI-Public: 00814548012537
• Combination Product (Y/N): Y
• 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,Followup,Followup
• Report Date (Section B): 05/11/2017
• Report Date (Section F): 01/01/2005

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: 05/31/2017
• Device Model Number: PXSLIM130-B
• Device Catalogue Number: PXSLIM130
• Device Lot Number: F43247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 07/05/2017; 01/14/2005
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/28/2017; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005