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

Catalog Number	PXSLIM090-B
Medical Device Problem Codes	Fracture (1260); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was stretched and fractured approximately 146.0 cm from the hub and stretched approximately 147.0 cm from the hub.Conclusions: evaluation of the returned device revealed the px slim was stretched and fractured in the distal shaft.This type of damage typically occurs due to forceful retraction of the px slim against resistance.The initial cause of the reported resistance could not be determined.The non-penumbra sheath mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) to treat an abdominal aortic aneurysm (aaa) using a px slim delivery microcatheter (px slim).During the procedure, the physician felt resistance after advancing the px slim about 15-20 cm into the non-penumbra sheath.The physician then felt resistance while retracting to remove the px slim, and therefore the sheath was removed with the px slim inside.Upon removal, the physician saw that the tip of the px slim was fractured.The procedure was completed using a new sheath 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: 7327223
• Report Number: 3005168196-2018-00532
• Device Sequence Number: 110194
• Product Code: DQY
• UDI-Device Identifier: 00814548012520
• UDI-Public: 00814548012520
• 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): 02/12/2018

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: 01/31/2019
• Device Catalogue Number: PXSLIM090-B
• Device Lot Number: F67433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 65